K900654 is an FDA 510(k) clearance for the MODIFIED CAPTIA(R) SYPHILIS-M. 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 March 8, 1990, 27 days after receiving the submission on February 9, 1990.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K900654 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1990 |
| Decision Date | March 08, 1990 |
| Days to Decision | 27 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 |