510(k) K852946 ยท DLZ Enzyme Immunoassay, Phenobarbital
SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT
| Applicant | Miles Laboratories, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Sep 30, 1985 |
| Received | Jul 11, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852946
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.