K770092 is an FDA 510(k) clearance for the HERPESIVIRUS TEST (TYPE L & 2). This device is classified as a Antigen, Ha (including Ha Control), Rubella (Class II - Special Controls, product code GOL).
Submitted by Microbiological Research Corp. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977, 43 days after receiving the submission on January 17, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K770092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 1977 |
| Decision Date | March 01, 1977 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | GOL — Antigen, Ha (including Ha Control), Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |