K941198 is an FDA 510(k) clearance for the EBV LGG ELISA TEST. This device is classified as a Epstein-barr Virus, Other (Class I - General Controls, product code LSE).
Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 23, 1995, 527 days after receiving the submission on March 14, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3235.
| 510(k) Number | K941198 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 14, 1994 |
| Decision Date | August 23, 1995 |
| Days to Decision | 527 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LSE — Epstein-barr Virus, Other |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3235 |