K882490 is an FDA 510(k) clearance for the HYCEL QUICK-LYSING HEMOGLOBIN REAGENT. This device is classified as a Diluent, Blood Cell (Class I - General Controls, product code GIF).
Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 25, 1988, 39 days after receiving the submission on June 16, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8200.
| 510(k) Number | K882490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 1988 |
| Decision Date | July 25, 1988 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GIF — Diluent, Blood Cell |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.8200 |