Data / Medical devices / United States / Labcorp Genetics
Labcorp Genetics: FDA-registered device maker in San Francisco, CA, United States, 4 510(k) clearances
Labcorp Genetics is registered with the FDA (registration 3013248161) in San Francisco, CA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 7, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013248161
- Address
- 1400 16th Street, San Francisco, CA, United States, 94103
- Owner or operator
- Labcorp Genetics (10087208)
- Roles
- Specification developer
- First device listed
- February 7, 2023
- Registered through
- 2027
- Brand names listed
- Blood Collection Kit, Blood NDD Collection Kit, Blood PCM Collection Kit, Buccal NDD Swab Specimen Collection Kit, Buccal Swab Specimen Collection Kit, Butterfly Needle Phlebotomy Kit, Cell-free PCM Collection Kit, RNA + Hereditary Cancer Blood Collection Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Collection Device For Cell-Free Nucleic Acid | QMA | 2 | Specification developer | accessdata.fda.gov |
| Blood Specimen Collection Convenience Kit (Excludes Hiv) | PQD | 2 | Specification developer | accessdata.fda.gov |
| Dna Specimen Collection, Saliva | OYJ | 2 | Specification developer | accessdata.fda.gov |
| Phlebotomy Blood Collection Kit | OFM | 2 | Specification developer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 7, 2020 | DEN200001 | Cell-Free DNA BCT | QMA | Unknown | Streck, Inc. | accessdata.fda.gov |
| May 26, 2016 | K152556 | Oragene Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| May 26, 2016 | K152464 | ORAcollect.Dx | OYJ | Substantially Equivalent | DNA Genotek, Inc. | accessdata.fda.gov |
| May 12, 1997 | K971236 | GREINER VACUETTE BLOOD COLLECTION TUBE | JKA | Substantially Equivalent | Greiner America, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Blood Specimen Collection Convenience Kit (Excludes Hiv)
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Dna Specimen Collection, Saliva
- All makers of Phlebotomy Blood Collection Kit
- All makers of Blood Collection Device For Cell-Free Nucleic Acid
Updated August 7, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.