510(k) K984323 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05
| 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 K984323
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2008 | Abbott Laboratories Architect LH MasterCheck (List 6C25-05). An in-vitro diagnostic, consisting of 4 - 2 mL vials of LH MasterCheck, Levels 0, 1, 2 and 3. Manufactured for Abbott Laboratories, Abbott Park, IL 60064.
A Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.