510(k) K013249 ยท DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control
TINA-QUANT APOLIPOPROTEIN VER.2
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Nov 16, 2001 |
| Received | Sep 28, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013249
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2018 | Roche Diagnostics Corporation COBAS INTEGRA 400 plus analyzer used in the following assays:
a)Tina-quant Apolipoprotein A-1 ver.2
Catalog Number: 03032566122
b)Tina-quant Albumin Gen.2
Catalog Number 04469658190
c)Creatinine p Terminated |
JJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.