Medical Device Manufacturer · US , South Lyon , MI

Omega Laboratories, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2010

9

Total

9

Cleared

0

Denied

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

8 devices

1-8 of 8

Cleared Jul 28, 2015

Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3,...

Toxicology · 301d

Cleared Jan 08, 2015

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND...

Toxicology · 296d

Cleared Nov 13, 2013

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES

Toxicology · 204d

Cleared Jun 25, 2013

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE

Toxicology · 61d

Cleared Dec 05, 2012

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA)

Toxicology · 86d

Cleared Jan 23, 2012

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES

Toxicology · 118d

Cleared Dec 13, 2011

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

Toxicology · 412d

Cleared Jul 12, 2010

OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE

Toxicology · 88d