MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE

Counter, Differential Cell

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Anti-human Cd3, T-cell/fitc & Cd19, B-cell/rpe.

Pre-market Notification Details

Device IDK960531
510k NumberK960531
Device Name:MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
ClassificationCounter, Differential Cell
Applicant DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
ContactGretchen M Murray
CorrespondentGretchen M Murray
DAKO CORP. 6392 VIA REAL Carpinteria,  CA  93013
Product CodeGKZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-07
Decision Date1996-06-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05700572028390 K960531 000

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