510(k) K913424 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
STACLOT(R) PROTEIN S TEST KIT
| Applicant | American Bioproducts Co., Parsippany NJ, US |
| Decision | Substantially Equivalent, Oct 8, 1991 |
| Received | Aug 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913424
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 28, 2026 | Diagnostica Stago, Inc. STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
qualitative and quantitative factor deficiency test Open, Classified |
GGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.