510(k) K973536 ยท DLJ Calibrators, Drug Specific
ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
| Applicant | Schiapparelli Biosystems, Inc., Fairfield NJ, US |
| Decision | Substantially Equivalent, Nov 6, 1997 |
| Received | Sep 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973536
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.