The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Indirect Fluoro-kit Hsv.
Device ID | K830623 |
510k Number | K830623 |
Device Name: | INDIRECT FLUORO-KIT HSV |
Classification | Antisera, Fluorescent, Herpesvirus Hominis 1,2 |
Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GQL |
CFR Regulation Number | 866.3305 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-28 |
Decision Date | 1983-07-07 |