K791117 is an FDA 510(k) clearance for the RABBIT COMPLEMENT. This device is classified as a Reagent, Complement (Class I - General Controls, product code KTQ).
Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979, 49 days after receiving the submission on June 15, 1979.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 866.4100.
| 510(k) Number | K791117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 1979 |
| Decision Date | August 03, 1979 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KTQ — Reagent, Complement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4100 |