K864888 is an FDA 510(k) clearance for the MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST. This device is classified as a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I - General Controls, product code LJP).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on February 25, 1987, 75 days after receiving the submission on December 12, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K864888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 1986 |
| Decision Date | February 25, 1987 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LJP — Antiserum, Fluorescent, Chlamydia Trachomatis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |