Panels › Hematology › Product code JBF · Class 2
Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Regulation 864.7360
0510(k)s in 12 months (5 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in JBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Pointe Scientific, Inc., | 1 | 1 |
| Alere Scarborough, Inc. | 1 | 0 |
| Baebies, Inc. | 1 | 0 |
| Binax, Inc. | 1 | 0 |
| Sigma Diagnostics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 31, 2015 | Pointe Scientific, Inc. Pointe Scientific G6PD Controls
Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3).
Also sold as individual vials
Bottle: Clear glass vials
Cap: Rubber seal with colored Terminated |
JBF | K024006 |
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