MONOCLONAL MOUSE ANTI-HUMAN T-CELL

Counter, Differential Cell

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Monoclonal Mouse Anti-human T-cell.

Pre-market Notification Details

Device IDK942797
510k NumberK942797
Device Name:MONOCLONAL MOUSE ANTI-HUMAN T-CELL
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 Received1994-06-15
Decision Date1994-11-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05700572028154 K942797 000

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