510(k) K873553 ยท JJB Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
WAKO(TM) PRETEST 8A
| Applicant | Wako Chemicals USA, Inc., Dallas TX, US |
| Decision | Substantially Equivalent, Sep 22, 1987 |
| Received | Aug 28, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K873553
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.