K033105 is an FDA 510(k) clearance for the CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT. This device is classified as a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 (Class II - Special Controls, product code MXJ).
Submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on July 13, 2004, 287 days after receiving the submission on September 30, 2003.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K033105 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2003 |
| Decision Date | July 13, 2004 |
| Days to Decision | 287 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 |