K161364 is an FDA 510(k) clearance for the BinaxNOW G6PD Test. This device is classified as a Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening (Class II - Special Controls, product code JBF).
Submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on June 17, 2016, 31 days after receiving the submission on May 17, 2016.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7360.
| 510(k) Number | K161364 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 17, 2016 |
| Decision Date | June 17, 2016 |
| Days to Decision | 31 days |
| Submission Type | Special |
| 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 |