510(k) K973451 ยท JJW Urinalysis Controls (Assayed And Unassayed)
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
| Applicant | Medical Analysis Systems, Inc., Camarillo CA, US |
| Decision | Substantially Equivalent, Sep 29, 1997 |
| Received | Sep 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973451
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2013 | Thermofisher Scientive MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Terminated |
JJW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.