510(k) K984324 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05
| Applicant | Bio-Rad, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 15, 1998 |
| Received | Dec 3, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984324
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2007 | Abbott Laboratories ARCHITECT Prolactin MasterCheck; a single analyte control - each kit contains 1 - 2 mL bottle of Architect Prolactin MasterCheck Level 0 containing HEPES buffer with protein (bovine) stabilizers, and Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.