510(k) K981638 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jun 12, 1998 |
| Received | May 8, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981638
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2010 | Beckman Coulter Inc IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280.
Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelome Terminated |
DCK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.