510(k) K981864 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 12, 1998 |
| Received | May 27, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 11, 2010 | Beckman Coulter Inc. Access Immunoassay Systems AFP QC, Part Number: 33219
The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprote Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.