510(k) K031380 ยท LCP Assay, Glycosylated Hemoglobin
OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
| Applicant | Olympus America, Inc., Irving TX, US |
| Decision | Substantially Equivalent, Nov 14, 2003 |
| Received | May 1, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2011 | Beckman Coulter Inc. Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472
Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c) Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.