Medical Device Manufacturer · US , Laguna Niguel , CA

Microdiagnostics, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1991

Recent clearances: MICRO-STRIP FOR PHENCYCLIDINE METABOLITES, MICRO-STRIP FOR MARIJUANA METABOLITES, MICRO-STRIP FOR COCAINE METABOLITES

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Microdiagnostics, Inc. Toxicology ✕

10 devices

1-10 of 10

Cleared Oct 25, 2001

DRUGS OF ABUSE MULTI-TEST STRIP

Toxicology · 126d

Cleared Aug 05, 1999

MICRO-STRIP FOR PHENCYCLIDINE METABOLITES

Toxicology · 98d

Cleared Aug 05, 1999

MICRO-STRIP FOR MARIJUANA METABOLITES

Toxicology · 97d

Cleared May 29, 1998

MICRO-STRIP FOR COCAINE METABOLITES

Toxicology · 43d

Cleared Mar 20, 1998

MICRO-STRIP FOR AMPHETAMINE METABOLITES

Toxicology · 99d

Cleared Dec 24, 1997

MICRO-STRIP FOR OPIATE METABOLITES

Toxicology · 83d

Cleared Dec 07, 1993

MICRO EIA FOR AMPHETAMINE METABOLITES

Toxicology · 209d

Cleared Sep 15, 1992

MICRO EIA FOR OPIATE METABOLITES

Toxicology · 63d

Cleared Dec 10, 1991

MICRO EIA FOR COCAINE METABOLITES

Toxicology · 60d

Cleared Nov 29, 1991

MICRO EIA FOR MARIJUANA METABOLITES

Toxicology · 52d