510(k) K971600 ยท DKB Calibrators, Drug Mixture
EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH)
| Applicant | Behring Diagnostics, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, Jun 25, 1997 |
| Received | May 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971600
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.