The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Indirect Immuno Enzyme,antigen,control.
Device ID | K791749 |
510k Number | K791749 |
Device Name: | INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL |
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 | 1979-09-10 |
Decision Date | 1979-10-17 |