ANA MICROZYME TEST SYS #1610

Igg, Peroxidase, Antigen, Antiserum, Control

CLINICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Ana Microzyme Test Sys #1610.

Pre-market Notification Details

Device IDK832675
510k NumberK832675
Device Name:ANA MICROZYME TEST SYS #1610
ClassificationIgg, Peroxidase, Antigen, Antiserum, Control
Applicant CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDAA  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-09
Decision Date1983-09-12

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