K993754 is an FDA 510(k) clearance for the HSV-1 ELISA IGG, MODEL EL0910G. This device is classified as a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II - Special Controls, product code MXJ).
Submitted by Mrl Diagnostics (Cypress, US). The FDA issued a Cleared decision on February 9, 2000, 96 days after receiving the submission on November 5, 1999.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K993754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1999 |
| Decision Date | February 09, 2000 |
| Days to Decision | 96 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MXJ — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |