510(k) K924122 ยท JPD Hemoglobin A2 Quantitation
VARIANT BETA-THALASSEMIA SHORT PROGRAM
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, Mar 11, 1993 |
| Received | Aug 14, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924122
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Sep 11, 2008 | Bio-Rad Laboratories Inc VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0019 (250 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104 Terminated |
JPD | None listed |
| Sep 11, 2008 | Bio-Rad Laboratories Inc VARIANT -thalassemia Short Program Hemoglobin Testing System, Model Number 270-0002 (500 tests), with -thalassemia ROM card lot PA 62600, PIN 2700104 Terminated |
JPD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.