510(k) K905280 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
BIOTROL BILIRUBIN C & T CONTROL
| Applicant | Biotrol, USA, Inc., Westchester PA, US |
| Decision | Substantially Equivalent, Feb 4, 1991 |
| Received | Nov 23, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905280
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.