K823010 is an FDA 510(k) clearance for the MICRO TRAK CHLAMYDIA TRACHOMATIS CULT. 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 December 15, 1982, 64 days after receiving the submission on October 12, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K823010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1982 |
| Decision Date | December 15, 1982 |
| Days to Decision | 64 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 |