Data / Medical devices / United States / Clinical Reference Laboratory, Inc.
Clinical Reference Laboratory, Inc.: FDA-registered device maker in Lenexa, KS, United States, 2 510(k) clearances
Clinical Reference Laboratory, Inc. is registered with the FDA (registration 1910144) in Lenexa, KS, United States. It lists 20 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 12, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1910144
- Address
- 8433 Quivira Rd, Lenexa, KS, United States, 66215
- Owner or operator
- Clinical Reference Laboratory (10038059)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- September 9, 2011
- Registered through
- 2027
- Brand names listed
- CRL Collection Kit, CRL Stat, CRL-Stat
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 |
|---|---|---|---|---|---|---|
| August 12, 2021 | K210327 | First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup | QBF | Substantially Equivalent | W.H.P.M., Inc. | accessdata.fda.gov |
| May 23, 2016 | K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | JXM | Substantially Equivalent | Healgen Scientific,, LLC | accessdata.fda.gov |
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Updated August 12, 2021. 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.