# Omega Laboratories, Inc.

- Location (FDA's records): Mogadore, OH
- FDA decisions: 9 (2010–2015): 9 510(k) clearances
- Product codes: DIO (2), DJG (2), LCM (2), DKZ (1), LDJ (1), LAF (1)
- Predicates its devices cite: 11 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Quest Diagnostics, Inc.: 4 (https://510kreport.com/company/quest-diagnostics)
- Psychemedics Corp.: 2 (https://510kreport.com/company/psychemedics)
- American Bio Medica Corp.: 1 (https://510kreport.com/company/american-bio-medica)

## Its most-cited devices
- K112808: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (2012), cited by 1
- K103161: Omega Laboratories Hair Drug Screening Assay for Opiates (2011), cited by 1
- K101059: Omega Laboratories Hair Drug Screening Assay for Phencyclidine (2010), cited by 1
- K101973: Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (Mdma) (2011), cited by 1

## Recent decisions
- K142855: Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) (Jul 28, 2015)
- K140671: Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone (Jan 8, 2015)
- K131128: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Nov 13, 2013)
- K131181: Omega Laboratories Hair Drug Screening Assay  Phencyclidine (Jun 25, 2013)
- K122759: Omega Laboratories Hair Drug Screening Assay Cardoxy-THC (Thca) (Dec 5, 2012)
- K112808: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Jan 23, 2012)
- K103161: Omega Laboratories Hair Drug Screening Assay for Opiates (Dec 13, 2011)
- K101973: Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (Mdma) (Aug 16, 2011)

Source page: https://510kreport.com/company/omega-laboratories