510(k) K020489 ยท JPD Hemoglobin A2 Quantitation
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, May 14, 2002 |
| Received | Feb 13, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020489
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2013 | Tosoh Bioscience Inc G7 HPLC.
Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood. Terminated |
JPD | None listed |
| Aug 17, 2011 | Tosoh Bioscience Inc Hemoglobin F & A2 Calibrator,
0.2 mL, 4 brown glass vials/box.
Mfr. By: Tosoh Bioscience,
Minato-ku, Tokyo, Japan.
Hemoglobin F & A2 Calibrator is used as in-vitro calibration material for Beta-th Terminated |
JPD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.