ACCESS ALLERGEN DOG EPITHELIM

System, Test, Radioallergosorbent (rast) Immunological

BIO-RAD LABORATORIES, INC.

The following data is part of a premarket notification filed by Bio-rad Laboratories, Inc. with the FDA for Access Allergen Dog Epithelim.

Pre-market Notification Details

Device IDK953780
510k NumberK953780
Device Name:ACCESS ALLERGEN DOG EPITHELIM
ClassificationSystem, Test, Radioallergosorbent (rast) Immunological
Applicant BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
ContactJoan Christenson
CorrespondentJoan Christenson
BIO-RAD LABORATORIES, INC. 1000 LAKE HAZELTINE DR. Chaska,  MN  55318 -1084
Product CodeDHB  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-14
Decision Date1995-11-14

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