Submission Details
| 510(k) Number | K201049 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
FINDER G6PD
Sep 2022
Decision
876d
Days
Class 2
Risk
About This 510(k) Submission
K201049 is an FDA 510(k) clearance for the FINDER G6PD, 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 review panel. Regulated under 21 CFR 864.7360.
Device Classification
| Product Code | JBF — Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 864.7360 |
Manufacturer
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