K904524 is an FDA 510(k) clearance for the CAPTIA(R) SYPHILIS M, MODIFICATION. This device is classified as a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II - Special Controls, product code LIP).
Submitted by Mercia Diagnostics , Ltd. (Guildford, Surrey England, GB). The FDA issued a Cleared decision on December 26, 1990, 90 days after receiving the submission on September 27, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K904524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1990 |
| Decision Date | December 26, 1990 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |