The following data is part of a premarket notification filed by Apple Diagnostic Products with the FDA for Adp Ifa Test For Chlamydiae Trachomatis.
| Device ID | K834242 |
| 510k Number | K834242 |
| Device Name: | ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | APPLE DIAGNOSTIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-06 |
| Decision Date | 1984-03-02 |