TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG

Iga, Antigen, Antiserum, Control

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Tissue-tek Immunohistology Kit Iga/igg.

Pre-market Notification Details

Device IDK842468
510k NumberK842468
Device Name:TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
ClassificationIga, Antigen, Antiserum, Control
Applicant MILES LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCZP  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-25
Decision Date1984-08-28

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