JBF
5 FDA 510(k) clearances · Product code
295 daysmedian time to decision
876 days90th percentile
5clearances measured
FDA profile
- Official device name
- Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7360
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FINDER G6PD (K201049) | Baebies, Inc. | 2022-09-14 |
| BinaxNOW G6PD Test (K161364) | Alere Scarborough, Inc. | 2016-06-17 |
| BINAXNOW G6PD TEST (K080003) | Binax, Inc. | 2008-10-23 |
| G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE (K024006) | Pointe Scientific, Inc., | 2003-03-31 |
| GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A (K933934) | Sigma Diagnostics, Inc. | 1995-06-29 |
Track JBF automatically
Every clearance here is in the API, with alerts when new ones post.