Data / Medical devices / United States / Molecular Testing Labs
Molecular Testing Labs: FDA-registered device maker in Vancouver, WA, United States, 6 510(k) clearances
Molecular Testing Labs is registered with the FDA (registration 3012598266) in Vancouver, WA, United States. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 29, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012598266
- Address
- 14401 SE 1ST Street, Vancouver, WA, United States, 98684
- Owner or operator
- Molecular Testing Labs (10081703)
- Roles
- Repackager or relabeler
- First device listed
- May 7, 2021
- Registered through
- 2026
- Brand names listed
- Abbott Alinity m STI Assay, Adhesive bandage, Collection Kit - Colorectal Cancer Screen, Collection Kit - DNA Buccal Swab, Dried Blood Spot Card, Fecal FIT PolyMed, Gauze pad, Hologic Aptima Urine and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 29, 2022 | K202977 | Alinity m STI Assay | QEP | Substantially Equivalent | Abbott Molecular, Inc. | accessdata.fda.gov |
| June 13, 2018 | K180681 | Aptima Combo 2 Assay (Panther System) | LSL | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| December 2, 2013 | K132270 | COBAS CT/NG V2.0 TEST | LSL | Substantially Equivalent | Roche Molecular Systems, Inc. | accessdata.fda.gov |
| October 21, 2004 | K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | OOX | Substantially Equivalent | Polymedco, Inc. | accessdata.fda.gov |
| June 17, 1998 | K981013 | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE | JKA | Substantially Equivalent for Some Indications | Becton Dickinson Vacutainer Systems | accessdata.fda.gov |
| July 23, 1993 | K932725 | B-D ULTRA FINE(R) LANCET | FMK | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
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Updated April 29, 2022. 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.