510(k) K984268 ยท LCP Assay, Glycosylated Hemoglobin
VARIANT II HEMOGLOBIN A1C PROGRAM
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Dec 17, 1998 |
| Received | Nov 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 25, 2010 | Bio-Rad Laboratories Inc VARIANT II Hemoglobin Testing System with CDM 3.5 Software Version 3.5; Model Number: 270-2000; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA.
Provi Terminated |
LCP | None listed |
| Jun 25, 2010 | Bio-Rad Laboratories Inc VARIANT II TURBO Hemoglobin Testing System with CDM 3.6T Software Version 3.5; Model Number: 270-2600; Product is manufactured and distributed by Bio-Rad Laboratories, Diagnostics Group, Hercules, CA. Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.