510(k) K981914 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Nov 26, 1999 |
| Received | Jun 1, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981914
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.