510(k) K844442 ยท LIB Device, General Purpose, Microbiology, Diagnostic
RAPID DIAGNOSTIC KIT
| Applicant | Portable Medical Laboratories, Inc., Solana Beach CA, US |
| Decision | Substantially Equivalent, Feb 1, 1985 |
| Received | Nov 16, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K844442
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.