K790767 is an FDA 510(k) clearance for the IMMU-TEK AUTOMATIC CENTRIFUGE. This device is classified as a Centrifuge, Cell-washing, Automated For Immuno-hematology (Class II - Special Controls, product code KSN).
Submitted by Dade, Baxter Travenol Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 23, 1979, 34 days after receiving the submission on April 19, 1979.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9285.
| 510(k) Number | K790767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 19, 1979 |
| Decision Date | May 23, 1979 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KSN — Centrifuge, Cell-washing, Automated For Immuno-hematology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.9285 |