510(k) K921939 ยท LAS Drug Specific Control Materials
SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)
| Applicant | Heraeus Kulzer, Inc., Mishawaka IN, US |
| Decision | Substantially Equivalent, Jul 16, 1992 |
| Received | Apr 24, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921939
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.