Prometheus Bio Inc

FDA Filings

This page includes the latest FDA filings for Prometheus Bio Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011559327
• FEI Number: 3011559327
• Name: Prometheus Bio Inc.
• Owner & Operator: Prometheus Bio Inc.
• Contact Address: No. 17, 14 Street, Hangzhou Economic And ; Hangzhou CN-33 Zhejiang 310018 CN
• Official Correspondent:
  • Tiger zhang
  • 86-571-86737118-x
• US Agent:
  • Mark Kowalski
  • Saxon Interglobal Associates, Limited Company
  • 307 4290222
  • mkowalski@sia-ltd.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: No. 17, 14 Street, Hangzhou Economic And Technological Developme ; Hangzhou Zhejiang, 310018 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
QKO Prometheus Bio Inc.	COVID-19 IgG/IgM Rapid Test Device	2020-03-30
LYU Prometheus Bio Inc.	Non-Surgical/Non-Sterile Facemask	2020-03-16
PMN K132812 | LFG Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | LDJ Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | LCM Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | JXN Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | JXM Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | DKZ Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | DJR Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | DJG Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | DJC Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | DIS Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K132812 | DIO Prometheus Bio Inc.	UCP Multi-Drug Test Key Cups	2017-10-16
PMN K061457 | LFG Prometheus Bio Inc.	UCP RAPID DRUG SCREENING	2017-10-16
PMN K061457 | LFG Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K061457 | JXN Prometheus Bio Inc.	UCP RAPID DRUG SCREENING	2017-10-16
PMN K061457 | JXN Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K050540 | LDJ Prometheus Bio Inc.	UCP RAPID DRUG SCREE	2017-10-16
PMN K050540 | LDJ Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K050540 | LCM Prometheus Bio Inc.	UCP RAPID DRUG SCREE	2017-10-16
PMN K050540 | LCM Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K050540 | JXM Prometheus Bio Inc.	UCP RAPID DRUG SCREE	2017-10-16
PMN K050540 | JXM Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K050540 | DKZ Prometheus Bio Inc.	UCP RAPID DRUG SCREE	2017-10-16
PMN K050540 | DKZ Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K050540 | DJR Prometheus Bio Inc.	UCP RAPID DRUG SCREE	2017-10-16
PMN K050540 | DJR Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K050540 | DJG Prometheus Bio Inc.	UCP RAPID DRUG SCREE	2017-10-16
PMN K050540 | DJG Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K050540 | DJC Prometheus Bio Inc.	UCP RAPID DRUG SCREE	2017-10-16
PMN K050540 | DJC Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K050540 | DIS Prometheus Bio Inc.	UCP RAPID DRUG SCREE	2017-10-16
PMN K050540 | DIS Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K050540 | DIO Prometheus Bio Inc.	UCP RAPID DRUG SCREE	2017-10-16
PMN K050540 | DIO Prometheus Bio Inc.	UCP RAPID DRUG SCR	2017-10-16
PMN K151213 | LFG Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | LDJ Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | LCM Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | JXN Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | JXM Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | DKZ Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | DJR Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | DJG Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | DJC Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | DIS Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K151213 | DIO Prometheus Bio Inc.	UCP Mini Drug Test Cups	2017-10-15
PMN K131811 | LFG Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | LDJ Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | LCM Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | JXN Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | JXM Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | DKZ Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | DJR Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | DJG Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | DJC Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | DIS Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K131811 | DIO Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K130463 | LFG Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | LDJ Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | LCM Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | JXN Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | JXM Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | DKZ Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | DJR Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | DJG Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | DJC Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | DIS Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K130463 | DIO Prometheus Bio Inc.	UCP Home Drug Screening Tests	2017-10-15
PMN K123863 | LFG Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K123863 | LDJ Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K123863 | LCM Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K123863 | JXM Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K123863 | DMB Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K123863 | DKZ Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K123863 | DJG Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K123863 | DJC Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K123863 | DIS Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K123863 | DIO Prometheus Bio Inc.	UCP Compact Drug Tests	2017-10-15
PMN K122419 | LFG Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K122419 | LDJ Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K122419 | LCM Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K122419 | JXM Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K122419 | DKZ Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K122419 | DJR Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K122419 | DJG Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K122419 | DJC Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K122419 | DIS Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K122419 | DIO Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K110515 | LFG Prometheus Bio Inc.	UCP Drug Screening Test Cups	2017-10-15
PMN K110515 | LDJ Prometheus Bio Inc.	UCP Drug Screening Test Cups	2017-10-15
PMN K110515 | LCM Prometheus Bio Inc.	UCP Drug Screening Test Cups	2017-10-15
PMN K110515 | JXM Prometheus Bio Inc.	UCP Drug Screening Test Cups	2017-10-15
PMN K110515 | DJR Prometheus Bio Inc.	UCP Drug Screening Test Cups	2017-10-15
PMN K110515 | DJG Prometheus Bio Inc.	UCP Drug Screening Test Cups	2017-10-15
PMN K110515 | DJC Prometheus Bio Inc.	UCP Drug Screening Test Cups	2017-10-15
PMN K110515 | DIS Prometheus Bio Inc.	UCP Drug Screening Test Cups	2017-10-15
PMN K110515 | DIO Prometheus Bio Inc.	UCP Drug Screening Test Cups	2017-10-15
PMN K091612 | DKZ Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091612 | DJG Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091612 | DIO Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | LFG Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | LDJ Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | LCM Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | JXM Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | DMB Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | DKZ Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | DJG Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | DJC Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | DIS Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K091588 | DIO Prometheus Bio Inc.	UCP Home Drug Screening Test Cups	2017-10-15
PMN K072062 | LFG Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | LDJ Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | LCM Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | JXN Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | JXM Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | DKZ Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | DJR Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | DJG Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | DJC Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | DIS Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15
PMN K072062 | DIO Prometheus Bio Inc.	UCP Multiple Drug Screen Test Cups	2017-10-15

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020081215024	Shanghai ,China (Mainland) -> Tampa, Florida	TEST CARDS	477 CTN
2020072159024	Shanghai ,China (Mainland) -> Long Beach, California	TEST CARDS	190 CTN
2020061041002	Shanghai ,China (Mainland) -> Long Beach, California	TEST CARDS	32 PKG
202006101463	Shanghai ,China (Mainland) -> Los Angeles, California	TEST CARDS	16 CTN
2020050122890	Shanghai ,China (Mainland) -> Oakland, California	TEST CARDSDRUG TEST CUP READER	17 CTN
202004279127	Pusan,South Korea -> Tampa, Florida	TEST CARDS, INSERT	604 CTN
202004279127	Pusan,South Korea -> Tampa, Florida	TEST CARDS, INSERT	604 CTN
2020042239721	Shanghai ,China (Mainland) -> Los Angeles, California	TEST CARDS	16 CTN
2020041529099	Shanghai ,China (Mainland) -> Long Beach, California	TEST CARDS	26 PKG