K834242 is an FDA 510(k) clearance for the ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS. This device is classified as a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I - General Controls, product code LJP).
Submitted by Apple Diagnostic Products (Mchenry, US). The FDA issued a Cleared decision on March 2, 1984, 87 days after receiving the submission on December 6, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K834242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1983 |
| Decision Date | March 02, 1984 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LJP — Antiserum, Fluorescent, Chlamydia Trachomatis |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |