Panels › Hematology › Product code JPB · Class 2
Hemoglobin M
Regulation 864.7415
0510(k)s in 12 months (0 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in JPB
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories, Inc. | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2017 | Helena Laboratories, Inc. Cascade Abrazo c-ACT-LR Test Card
IVD FOR IN VITRO DIAGNOSTIC USE
Store at 2 to 8 C
HELENA LABORATORIES
003366
12/13(2)
FOR EXPORT ONLY Terminated |
JPB | None listed |
| Apr 20, 2016 | Helena Laboratories, Inc. Cascade Abrazo c-ACT-LR Test Card
IVD FOR IN VITRO DIAGNOSTIC USE
Store at 2 to 8 C
HELENA LABORATORIES
003366
12/13(2)
FOR EXPORT ONLY
The Cascade Abrazo c-ACT-LR test cards are activated clotting Terminated |
JPB | None listed |
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