K980596 is an FDA 510(k) clearance for the VCA IGM ELISA TEST SYSTEM. This device is classified as a Epstein-barr Virus, Other (Class I - General Controls, product code LSE).
Submitted by Clark Laboratories, Inc. (Frederick, US). The FDA issued a Cleared decision on July 22, 1998, 155 days after receiving the submission on February 17, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K980596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 1998 |
| Decision Date | July 22, 1998 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSE — Epstein-barr Virus, Other |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |