K790380 is an FDA 510(k) clearance for the LOW-TOX-H RABBIT COMPLEMENT. This device is classified as a Reagent, Complement (Class I - General Controls, product code KTQ).
Submitted by Cederlane Labs , Ltd. (Mchenry, US). The FDA issued a Cleared decision on March 21, 1979, 22 days after receiving the submission on February 27, 1979.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 866.4100.
| 510(k) Number | K790380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1979 |
| Decision Date | March 21, 1979 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | KTQ — Reagent, Complement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4100 |