K843622 is an FDA 510(k) clearance for the ABBOTT HSV EIA. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II - Special Controls, product code LGC).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 20, 1985, 248 days after receiving the submission on September 14, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K843622 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1984 |
| Decision Date | May 20, 1985 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| 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 |