The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Cytomegalovirus Antibody Fluoro-kit Ii.
Device ID | K833089 |
510k Number | K833089 |
Device Name: | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II |
Classification | Antigen, Cf (including Cf Control), Cytomegalovirus |
Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GQH |
CFR Regulation Number | 866.3175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-12 |
Decision Date | 1984-05-02 |