The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Pathodx Chlamydia Trachomatis Direct Specimen Test.
| Device ID | K900870 |
| 510k Number | K900870 |
| Device Name: | PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-24 |
| Decision Date | 1990-04-16 |