DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37

Counter, Differential Cell

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, Cd19/rpe-cy5, Clone Hd37.

Pre-market Notification Details

Device IDK980635
510k NumberK980635
Device Name:DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
ClassificationCounter, Differential Cell
Applicant DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
ContactGretchen M Murray, Ph.d., Rac
CorrespondentGretchen M Murray, Ph.d., Rac
DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-19
Decision Date1998-07-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05700572028345 K980635 000

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