K790211 is an FDA 510(k) clearance for the DEHYDROGENOSE, GLUCOSE PHOSPHATE. This device is classified as a Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative (Class II - Special Controls, product code JBL).
Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1979, 43 days after receiving the submission on January 31, 1979.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7360.
| 510(k) Number | K790211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1979 |
| Decision Date | March 15, 1979 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JBL — Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7360 |