DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI

Lambda, Antigen, Antiserum, Control

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Dako Mouse Anti-human B-cell (dako-c020-l26 Mono Anti.

Pre-market Notification Details

Device IDK924726
510k NumberK924726
Device Name:DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI
ClassificationLambda, Antigen, Antiserum, Control
Applicant DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
ContactKim Kosai
CorrespondentKim 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 Received1992-09-21
Decision Date1994-06-13

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