Omega Laboratories, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Omega Laboratories, Inc.” (first 2010, latest 2015), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 204 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 102 |
| 2013 | 2 | 132 |
| 2014 | 0 | — |
| 2015 | 2 | 298 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | 2 |
| DJG | Enzyme Immunoassay, Opiates | 2 | 2 |
| LCM | Enzyme Immunoassay, Phencyclidine | 2 | 2 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 | 1 |
Review panels
Most recent Omega Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) | DKZ | 2015-07-28 | 301 |
| K140671 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES, OXYCODONE AND HYDROCODONE | DJG | 2015-01-08 | 296 |
| K131128 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | DIO | 2013-11-13 | 204 |
| K131181 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE | LCM | 2013-06-25 | 61 |
| K122759 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY CARDOXY-THC (THCA) | LDJ | 2012-12-05 | 86 |
| K112808 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES | DIO | 2012-01-23 | 118 |
| K103161 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES | DJG | 2011-12-13 | 412 |
| K101973 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) | LAF | 2011-08-16 | 399 |
| K101059 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE | LCM | 2010-07-12 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Omega Laboratories, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Omega Medical Electronics (21 510(k)s)
- Omega-Med Intl., Inc. (9 510(k)s)
- Omega Medical Imaging, Inc. (8 510(k)s)
- Omega Medical Imaging, LLC (7 510(k)s)
- Omega Medical Diagnostics (5 510(k)s)
- Omega Silicone, Inc. (5 510(k)s)
- Omega Surgical Instruments, Inc. (3 510(k)s)
- Omega Universal Technologies, Ltd. (3 510(k)s)
- Omega Medical Corp. (2 510(k)s)
- Omega Critical Care Limited (1 510(k)s)
- Omega Group, Inc. (1 510(k)s)
- Omega Hearing Aid Center (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Omega Laboratories, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Omega Laboratories, Inc.” (first 2010, latest 2015), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Omega Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Omega Laboratories, Inc. is 204 days.
Which FDA product codes appear under Omega Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 2); DJG (Enzyme Immunoassay, Opiates, 2); LCM (Enzyme Immunoassay, Phencyclidine, 2).
Next steps
- See all 9 Omega Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Omega Laboratories, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.