JBF — Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening Class II
FDA product code JBF covers "Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening", a Class II medical device regulated under 21 CFR 864.7360. Submissions are reviewed by the Hematology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JBF
- Device Class
- Class II
- Regulation Number
- 864.7360
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201049 | baebies | FINDER G6PD | September 14, 2022 |
| K161364 | alere scarborough | BinaxNOW G6PD Test | June 17, 2016 |
| K080003 | binax | BINAXNOW G6PD TEST | October 23, 2008 |
| K024006 | pointe scientific, inc | G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE | March 31, 2003 |
| K933934 | sigma diagnostics | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A | June 29, 1995 |