K942276 is an FDA 510(k) clearance for the QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY. This device is classified as a Hemoglobin S (Class II - Special Controls, product code GIQ).
Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on January 20, 1995, 255 days after receiving the submission on May 10, 1994.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7415.
| 510(k) Number | K942276 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1994 |
| Decision Date | January 20, 1995 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GIQ — Hemoglobin S |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7415 |