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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 14, 2022 | K201049 | FINDER G6PD Baebies, Inc. | JBF |
| Jun 17, 2016 | K161364 | BinaxNOW G6PD Test Alere Scarborough, Inc. | JBF |
| Oct 23, 2008 | K080003 | BINAXNOW G6PD TEST Binax, Inc. | JBF |
| Mar 31, 2003 | K024006 | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE Pointe Scientific, Inc., | JBF |
| Jun 29, 1995 | K933934 | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A Sigma Diagnostics, Inc. | JBF |
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