Panels › Hematology › Product code JPD · Class 2
Hemoglobin A2 Quantitation
Regulation 864.7400
0510(k)s in 12 months (13 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in JPD
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 6 | 0 |
| Bio-Rad | 4 | 0 |
| Bio-Rad Laboratories Inc | 0 | 3 |
| Tosoh Bioscience Inc | 0 | 2 |
| Drew Scientific , Ltd. | 1 | 0 |
| Isolab, Inc. | 1 | 0 |
| Tosoh Medics, Inc. | 1 | 0 |
| 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 | K991127 |
| 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 | K011434 K020489 |
| 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 | K020489 |
| 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 | K924122 |
| 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 | K924122 |
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