Omega Laboratories, Inc.
Mogadore, OH, US
OMEGA LABORATORIES, INC. appears in FDA device records in Mogadore, OH. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Omega Laboratories, Inc. between 2010 and 2015. The busiest year on record is 2011, with 2. The most recent is 2015, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 2 |
| 2015 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) | DKZ | Substantially Equivalent | |
| K140671 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE | DJG | Substantially Equivalent | |
| K131128 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | DIO | Substantially Equivalent | |
| K131181 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE | LCM | Substantially Equivalent | |
| K122759 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) | LDJ | Substantially Equivalent | |
| K112808 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | DIO | Substantially Equivalent | |
| K103161 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES | DJG | Substantially Equivalent | |
| K101973 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) | LAF | Substantially Equivalent | |
| K101059 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE | LCM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004847291 | 3004847291 | OMEGA LABORATORIES, INC. | 400 N CLEVELAND AVE, MOGADORE, OH 44260 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The Counter
- DJZDevices, Breath Trapping, Alcohol
- DKZEnzyme Immunoassay, Amphetamine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- LAFGas Chromatography, Methamphetamine
- PUXTest, Amphetamine, Employment And Insurance Testing, Exempt
- PUZTest, Benzodiazepine, Employment And Insurance Testing, Exempt
- PVJTest, Cannabinoid, Employment And Insurance Testing, Exempt
- PVATest, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt
- PVDTest, Methamphetamine, Employment And Insurance Testing, Exempt
- PVHTest, Opiates, Employment And Insurance Testing, Exempt
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain