510(k) K991075 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ATLAST GLUCOSE CONTROL SOLUTION
| Applicant | Amira Medical, Inc., Scotts Valley CA, US |
| Decision | Substantially Equivalent, May 10, 1999 |
| Received | Mar 31, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991075
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.