510(k) K991127 ยท JPD Hemoglobin A2 Quantitation
VARIANT II B-THALASSEMIA
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Jun 10, 1999 |
| Received | Apr 2, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K991127
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 2, 2014 | Bio-Rad Laboratories, Inc. Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses t Terminated |
JPD | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made Terminated |
LCP | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made Terminated |
LCP | None listed |
| Oct 7, 2011 | Bio-Rad Laboratories, Inc. VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,.
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood u Terminated |
LCP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.