510(k) K971519 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
ASSERACHROM TPA TEST KIT
| Applicant | American Bioproducts Co., Parisppany NJ, US |
| Decision | Substantially Equivalent, Aug 19, 1997 |
| Received | Apr 25, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971519
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.