K990957 is an FDA 510(k) clearance for the ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K. This device is classified as a Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative (Class II - Special Controls, product code JBL).
Submitted by Astoria-Pacific, Inc. (Clackamas, US). The FDA issued a Cleared decision on May 11, 1999, 50 days after receiving the submission on March 22, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7360.
| 510(k) Number | K990957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1999 |
| Decision Date | May 11, 1999 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JBL — Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7360 |