K021429 is an FDA 510(k) clearance for the HERPESELECT 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 Focus Technologies, Inc. (Cypress, US). The FDA issued a Cleared decision on July 29, 2002, 87 days after receiving the submission on May 3, 2002.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K021429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2002 |
| Decision Date | July 29, 2002 |
| Days to Decision | 87 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 |