K831871 is an FDA 510(k) clearance for the SICKLE-HEME A/S CONTROLS & A/A CONTROL. This device is classified as a Test, Sickle Cell (Class II - Special Controls, product code GHM).
Submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983, 45 days after receiving the submission on June 13, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.7825.
| 510(k) Number | K831871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1983 |
| Decision Date | July 28, 1983 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | GHM — Test, Sickle Cell |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7825 |