K910953 is an FDA 510(k) clearance for the HSV-2 IGM ELISA TEST. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II - Special Controls, product code LGC).
Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 28, 1991, 82 days after receiving the submission on March 7, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K910953 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 1991 |
| Decision Date | May 28, 1991 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LGC — Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |