The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Ana Microzyme Test Sys #1610.
Device ID | K832675 |
510k Number | K832675 |
Device Name: | ANA MICROZYME TEST SYS #1610 |
Classification | Igg, Peroxidase, Antigen, Antiserum, Control |
Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DAA |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-09 |
Decision Date | 1983-09-12 |