K820396 is an FDA 510(k) clearance for the AUTOMATED BLOOD CELL SEPAR. DISP. SFTWR. This device is classified as a Separator, Automated, Blood Cell, Diagnostic (Class II - Special Controls, product code GKT).
Submitted by Pheragen Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1982, 75 days after receiving the submission on February 11, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9245.
| 510(k) Number | K820396 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 11, 1982 |
| Decision Date | April 27, 1982 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GKT — Separator, Automated, Blood Cell, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9245 |