K842440 is an FDA 510(k) clearance for the SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH. This device is classified as a Mixture, Hematology Quality Control (Class II - Special Controls, product code JPK).
Submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1984, 36 days after receiving the submission on June 21, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.8625.
| 510(k) Number | K842440 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1984 |
| Decision Date | July 27, 1984 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JPK — Mixture, Hematology Quality Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.8625 |