K981306 is an FDA 510(k) clearance for the DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM. This device is classified as a Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (Class II - Special Controls, product code LGC).
Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 29, 1998, 172 days after receiving the submission on April 10, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K981306 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1998 |
| Decision Date | September 29, 1998 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LGC — Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |