DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION

Lambda, Antigen, Antiserum, Control

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Labeled Streptavidin-biotin 2 Kit, And Envision.

Pre-market Notification Details

Device IDK951965
510k NumberK951965
Device Name:DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION
ClassificationLambda, Antigen, Antiserum, Control
Applicant DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
ContactKim M Kosai
CorrespondentKim M Kosai
DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
Product CodeDEH  
CFR Regulation Number866.5550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-27
Decision Date1996-07-05
Summary:summary

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