510(k) K973678 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
| Applicant | Sorrento Biochemical, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 15, 1997 |
| Received | Sep 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973678
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.