K820642 is an FDA 510(k) clearance for the SICKLE-CHECK. This device is classified as a Test, Sickle Cell (Class II - Special Controls, product code GHM).
Submitted by Panmed, Inc. (Walker, US). The FDA issued a Cleared decision on April 14, 1982, 37 days after receiving the submission on March 8, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7825.
| 510(k) Number | K820642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1982 |
| Decision Date | April 14, 1982 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GHM — Test, Sickle Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7825 |