510(k) K030044 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
EXTENDED RANGE HS CRP KIT, CAT NO:9200
| Applicant | Reference Diagnostics, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Sep 30, 2003 |
| Received | Jan 6, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030044
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.