K790105 is an FDA 510(k) clearance for the TERUMO IMUGARD. This device is classified as a Separator, Automated, Blood Cell, Diagnostic (Class II - Special Controls, product code GKT).
Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 24, 1979, 128 days after receiving the submission on January 16, 1979.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.9245.
| 510(k) Number | K790105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1979 |
| Decision Date | May 24, 1979 |
| Days to Decision | 128 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 |