K781392 is an FDA 510(k) clearance for the CYTOMEGILISH TEST KIT. This device is classified as a Antisera, Hai (including Hai Control), Rubella (Class II - Special Controls, product code GOK).
Submitted by Microbiological Assoc. (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978, 75 days after receiving the submission on August 10, 1978.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3510.
| 510(k) Number | K781392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1978 |
| Decision Date | October 24, 1978 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GOK — Antisera, Hai (including Hai Control), Rubella |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3510 |