510(k) K923731 ยท GFO Activated Partial Thromboplastin
STACLOT LA TEST KIT
| Applicant | American Bioproducts Co., Parsippany NJ, US |
| Decision | Substantially Equivalent, Dec 23, 1992 |
| Received | Jul 27, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923731
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2018 | Diagnostica Stago, Inc. Staclot LA (REF 00600)
The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase Terminated |
GFO | None listed |
| Nov 14, 2018 | Diagnostica Stago, Inc. Staclot LA 20 (REF 00594)
The Staclot LA and Staclot LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII pha Terminated |
GFO | None listed |
| Aug 26, 2006 | Diagnostica Stago, Inc. Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay. Terminated |
GFO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.