Bionime Usa Corp

FDA Filings

This page includes the latest FDA filings for Bionime Usa Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006755541
• FEI Number: 3006755541
• Name: BIONIME USA CORPORATION
• Owner & Operator: BIONIME USA CORPORATION
• Contact Address: 1450 E. Spruce Street, Bldg. #B ; Ontario CA 91761 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 1450 E. Spruce Street, Bldg. #B ; Ontario, CA 91761 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K190564 | NBW BIONIME USA CORPORATION	RIGHTEST	2020-01-27
PMN K143387 | NBW BIONIME USA CORPORATION	GE	2016-04-13
PMN K143387 | CGA BIONIME USA CORPORATION	GE	2016-04-13
PMN K141292 | NBW BIONIME USA CORPORATION	Rightest	2016-04-13
PMN K141292 | NBW BIONIME USA CORPORATION	GE	2016-04-13
PMN K141292 | LFR BIONIME USA CORPORATION	Rightest	2016-04-13
PMN K141292 | LFR BIONIME USA CORPORATION	GE	2016-04-13
PMN K140210 | NBW BIONIME USA CORPORATION	Rightest	2014-12-04
PMN K140210 | LFR BIONIME USA CORPORATION	Rightest	2014-12-04
PMN K133522 | NBW BIONIME USA CORPORATION	Rightest	2014-12-04
PMN K133522 | LFR BIONIME USA CORPORATION	Rightest	2014-12-04
PMN K133522 | JQP BIONIME USA CORPORATION	Rightest	2014-12-04
PMN K133522 | CGA BIONIME USA CORPORATION	Rightest	2014-12-04
PMN K133003 | JJX BIONIME USA CORPORATION	Rightest GC310, GC110, GC300, GC100	2013-10-29
PMN K123008 | NBW BIONIME USA CORPORATION	Rightest	2013-09-16
PMN K123008 | NBW BIONIME USA CORPORATION	GE	2013-09-16
PMN K123008 | LFR BIONIME USA CORPORATION	Rightest	2013-09-16
PMN K123008 | LFR BIONIME USA CORPORATION	GE	2013-09-16
PMN K113007 | NBW BIONIME USA CORPORATION	RighTest	2012-10-22
PMN K113007 | NBW BIONIME USA CORPORATION	GE	2012-10-22
PMN K113007 | NBW BIONIME USA CORPORATION	Bionime	2012-10-22
PMN K113007 | JQP BIONIME USA CORPORATION	RighTest	2012-10-22
PMN K113007 | JQP BIONIME USA CORPORATION	GE	2012-10-22
PMN K113007 | JQP BIONIME USA CORPORATION	Bionime	2012-10-22
PMN K110737 | NBW BIONIME USA CORPORATION	RighTest	2012-10-22
PMN K110737 | LFR BIONIME USA CORPORATION	RighTest	2012-10-22
PMN K110737 | JJX BIONIME USA CORPORATION	RighTest	2012-10-22
FMK BIONIME USA CORPORATION	Rightest	2011-11-17
FMK BIONIME USA CORPORATION	GE	2011-11-17
FMK BIONIME USA CORPORATION	Bionime	2011-11-17
PMN K092052 | NBW BIONIME USA CORPORATION	Rightest	2011-11-16
PMN K092052 | NBW BIONIME USA CORPORATION	Rightest GM250S, GM550, GM250, GM260	2011-11-16
PMN K092052 | NBW BIONIME USA CORPORATION	PSS World Medical Quintet AC System	2011-11-16
PMN K092052 | NBW BIONIME USA CORPORATION	GE GE100 System	2011-11-16
PMN K092052 | JJX BIONIME USA CORPORATION	Rightest	2011-11-16
PMN K092052 | JJX BIONIME USA CORPORATION	Rightest GM250S, GM550, GM250, GM260	2011-11-16
PMN K092052 | JJX BIONIME USA CORPORATION	PSS World Medical Quintet AC System	2011-11-16
PMN K092052 | JJX BIONIME USA CORPORATION	GE GE100 System	2011-11-16
PMN K092052 | CGA BIONIME USA CORPORATION	Rightest	2011-11-16
PMN K092052 | CGA BIONIME USA CORPORATION	Rightest GM250S, GM550, GM250, GM260	2011-11-16
PMN K092052 | CGA BIONIME USA CORPORATION	PSS World Medical Quintet AC System	2011-11-16
PMN K092052 | CGA BIONIME USA CORPORATION	GE GE100 System	2011-11-16
PMN K081451 | NBW BIONIME USA CORPORATION	Rightest	2011-11-16
PMN K081451 | CGA BIONIME USA CORPORATION	Rightest	2011-11-16
PMN K042678 | NBW BIONIME USA CORPORATION	Rightest	2011-11-16
PMN K042678 | JJX BIONIME USA CORPORATION	Rightest	2011-11-16
PMN K042678 | CGA BIONIME USA CORPORATION	Rightest	2011-11-16

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091548193	Taipei,China (Taiwan) -> Los Angeles, California	MEDICAL SUPPLY(BLOOD GLUCOSE TEST STRIP)	403 CTN
2020081245191	Taipei,China (Taiwan) -> Los Angeles, California	MEDICAL SUPPLY(BLOOD GLUCOSE MONITORING SYSTE M-METER ONLY)	413 CTN
2020080672288	Taipei,China (Taiwan) -> Los Angeles, California	MEDICAL SUPPLY(BLOOD GLUCOSE MONITORING SYSTE M-METER ONLY)	413 CTN
2020071437935	Taipei,China (Taiwan) -> Los Angeles, California	MEDICAL SUPPLY-RIGHTEST BLOOD GLUCOSE MONITOR ING SYSTEM-METER	243 CTN
2020061948996	Taipei,China (Taiwan) -> Los Angeles, California	MEDICAL SUPPLY(BLOOD GLUCOSE TEST STRIP)	250 CTN
2020051652061	Taipei,China (Taiwan) -> Los Angeles, California	MEDICAL SUPPLY(BLOOD GLUCOSE MONITORING SYSTE M-METER ONLY)	477 CTN
2020042429019	Taipei,China (Taiwan) -> Los Angeles, California	MEDICAL SUPPLY(GE BLOOD GLUCOSE MONITORING SY STEM)	322 CTN
2020031937494	Taipei,China (Taiwan) -> Los Angeles, California	MEDICAL SUPPLY	430 CTN