510(k) K994277 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ACCESS OSTASE QC
| Applicant | Beckman Coulter, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 14, 2000 |
| Received | Dec 20, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994277
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2012 | Beckman Coulter Inc. Access Ostase QC, Part Number: 37309.
The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay. Terminated |
JJX | None listed |
| Jun 21, 2011 | Beckman Coulter Inc. Access Immunoassay Systems
Quality Control Kits, Part Number: 37309
The Access Ostase QC is used for monitoring system performance of the Access Ostase assay. Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.