K243575 is an FDA 510(k) clearance for the ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls. This device is classified as a Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 (Class II - Special Controls, product code MYF).
Submitted by Biokit, S.A. (Lliçà D’Amunt, Barcelona, ES). The FDA issued a Cleared decision on February 12, 2025, 85 days after receiving the submission on November 19, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3305.
| 510(k) Number | K243575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2024 |
| Decision Date | February 12, 2025 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MYF — Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3305 |