Able Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Able Diagnostics 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: 3014128279
• FEI Number: 3014128279
• Name: ABLE DIAGNOSTICS, INC.
• Owner & Operator: Able Diagnostics, Inc.
• Contact Address: 12396 World Trade Drive, Suite 216 ; San Diego CA 92128 US
• Official Correspondent:
  • Lee Mariano
  • 01-858-2050751-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 12396 World Trade Drive, Suite 216, San Diego, CA 92128, ; San Diego, CA 92128 US

FDA Filings

Device Company	Device	Date
GUDID 00853483008144 Able Diagnostics Inc	VivaGuard VGL01-383	2021-02-17
GUDID 00853483008137 Able Diagnostics Inc	VivaGuard VGL02-382	2021-02-17
GUDID 00853483008038 Able Diagnostics Inc	VivaGuard VGD01-381	2021-02-17
GUDID 00853483008021 Able Diagnostics Inc	VivaGuard VGL01-382	2021-02-17
GUDID 00853483008243 Able Diagnostics Inc	VivaGuard Ino Smart	2021-02-11
GUDID 00853483008236 Able Diagnostics Inc	VivaGuard Ino Smart VGM04-665	2021-02-11
GUDID 00853483008199 Able Diagnostics Inc	VivaGuard Ino VGC01-372	2021-02-11
GUDID 00853483008182 Able Diagnostics Inc	VivaGuard Ino VGS01-378	2021-02-11
GUDID 00853483008175 Able Diagnostics Inc	VivaGuard Ino VGC01-373	2021-02-11
GUDID 00853483008076 Able Diagnostics Inc	VivaGuard Ino VGC01-371	2021-02-11
GUDID 00853483008151 Able Diagnostics Inc	VivaGuard Ino	2021-02-10
GUDID 00853483008052 Able Diagnostics Inc	VivaGuard Ino VGM01-373	2021-02-10
GUDID 00853483008014 Able Diagnostics Inc	VivaGuard Ino VGS01-371	2021-02-10
GUDID 00853483008007 Able Diagnostics Inc	VivaGuard Ino VGM01-371	2021-02-10
GUDID 00853483008250 Able Diagnostics Inc	VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer HA-650	2020-12-16

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082549855	Shanghai ,China (Mainland) -> Long Beach, California	BLOOD GLUCOSE TEST STRIPS AND SELL SHEET . . . .	57 CTN
2020082263114	Shanghai ,China (Mainland) -> Long Beach, California	BLOOD GLUCOSE TEST STRIPS AND SELL SHEET . . . .	57 CTN
2020052328586	Pusan,South Korea -> Los Angeles, California	LANCETS . . . .	75 CTN
2020050421025	Pusan,South Korea -> Los Angeles, California	SAFETY LANCETS . . . .	76 CTN
2020050139845	Shanghai ,China (Mainland) -> Long Beach, California	BLOOD GLUCOSE MONITORING SYSTEM . . . .	186 CTN
2020021927155	Pusan,South Korea -> Long Beach, California	LANCING DEVICE . . . .	25 CTN
2020020830664	Shanghai ,China (Mainland) -> Long Beach, California	BLOOD GLUCOSE MONITORING SYSTEM . . . .	53 CTN
2020020639997	Shanghai ,China (Mainland) -> Long Beach, California	BLOOD GLUCOSE MONITORING SYSTEM . . . .	53 CTN