K842623 is an FDA 510(k) clearance for the MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT. This device is classified as a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I - General Controls, product code LJP).
Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984, 28 days after receiving the submission on July 5, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K842623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 1984 |
| Decision Date | August 02, 1984 |
| Days to Decision | 28 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 |