K924091 is an FDA 510(k) clearance for the EBV-VCA IGG ELISA TEST SYSTEM. This device is classified as a Antigen, Ebv, Capsid (Class I - General Controls, product code MCD).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on January 11, 1993, 151 days after receiving the submission on August 13, 1992.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K924091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1992 |
| Decision Date | January 11, 1993 |
| Days to Decision | 151 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | MCD — Antigen, Ebv, Capsid |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |