MOUSE IGG1 NEGATIVE CONTROLS

Counter, Differential Cell

DAKO CORP.

The following data is part of a premarket notification filed by Dako Corp. with the FDA for Mouse Igg1 Negative Controls.

Pre-market Notification Details

Device IDK991454
510k NumberK991454
Device Name:MOUSE IGG1 NEGATIVE CONTROLS
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 Received1999-04-26
Decision Date1999-06-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05700572028499 K991454 000
05700572028482 K991454 000
05700572028475 K991454 000

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