K201049 is an FDA 510(k) clearance for the FINDER G6PD. This device is classified as a Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening (Class II - Special Controls, product code JBF).
Submitted by Baebies, Inc. (Morrisville, US). The FDA issued a Cleared decision on September 14, 2022, 876 days after receiving the submission on April 21, 2020.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7360.
| 510(k) Number | K201049 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 2020 |
| Decision Date | September 14, 2022 |
| Days to Decision | 876 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JBF - Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7360 |