Panels › Hematology › Product code JCM · Class 2
Control, Hemoglobin, Abnormal
Regulation 864.7415
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JCM
| Company | 510(k)s | Recalls |
|---|---|---|
| Isolab, Inc. | 4 | 0 |
| Helena Laboratories | 2 | 0 |
| Bio-Rad | 1 | 0 |
| Cantebury Scientific , Ltd. | 1 | 0 |
| Canterbury Health Laboratories | 1 | 0 |
| Creative Laboratory Products, Inc. | 1 | 0 |
| Diagnostic Technology, Inc. | 1 | 0 |
| Roche Diagnostic Systems, Inc. | 1 | 0 |
| Tosoh Bioscience, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2016 | Tosoh Bioscience, Inc. Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. Terminated |
JCM | K071132 K131580 |
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