The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Neisseria Gonorrhoeae Fluoro-kit.
Device ID | K800328 |
510k Number | K800328 |
Device Name: | NEISSERIA GONORRHOEAE FLUORO-KIT |
Classification | Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae |
Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GTH |
CFR Regulation Number | 866.3390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-12 |
Decision Date | 1980-03-03 |