K812369 is an FDA 510(k) clearance for the GUINEA PIG COMPLEMENT VIRUS ANTIBODY. This device is classified as a Reagent, Complement (Class I - General Controls, product code KTQ).
Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 8, 1981, 19 days after receiving the submission on August 20, 1981.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4100.
| 510(k) Number | K812369 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 1981 |
| Decision Date | September 08, 1981 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | KTQ — Reagent, Complement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4100 |