The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Chlamydia Fluoro-kit 1680.
| Device ID | K850158 |
| 510k Number | K850158 |
| Device Name: | CHLAMYDIA FLUORO-KIT 1680 |
| Classification | Antiserum, Fluorescent, Chlamydia Trachomatis |
| Applicant | CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
| Contact | Marylou Panico |
| Correspondent | Marylou Panico CLINICAL SCIENCES, INC. 30 TROY RD. Whippany, NJ 07981 |
| Product Code | LJP |
| CFR Regulation Number | 866.3120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-15 |
| Decision Date | 1985-03-21 |