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 |