K992166 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II - Special Controls, product code LGC).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on September 3, 1999, 70 days after receiving the submission on June 25, 1999.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K992166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1999 |
| Decision Date | September 03, 1999 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LGC — Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |