510(k) K964009 ยท DNO Hemagglutination Inhibition, Gentamicin
IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS
| Applicant | Beckman Instruments, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Feb 11, 1997 |
| Received | Oct 7, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964009
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.