510(k) K972160 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
| Applicant | Trinity Laboratories, Inc., Raleigh NC, US |
| Decision | Substantially Equivalent, Aug 1, 1997 |
| Received | Jun 9, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972160
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.