ACCURUN 146 CMV IGM POSITIVE CONTROL

Antibody Igm,if, Cytomegalovirus Virus

BOSTON BIOMEDICA, INC.

The following data is part of a premarket notification filed by Boston Biomedica, Inc. with the FDA for Accurun 146 Cmv Igm Positive Control.

Pre-market Notification Details

Device IDK972884
510k NumberK972884
Device Name:ACCURUN 146 CMV IGM POSITIVE CONTROL
ClassificationAntibody Igm,if, Cytomegalovirus Virus
Applicant BOSTON BIOMEDICA, INC. 375 WEST ST. West Bridgewater,  MA  02379
ContactPatricia E Garrett
CorrespondentPatricia E Garrett
BOSTON BIOMEDICA, INC. 375 WEST ST. West Bridgewater,  MA  02379
Product CodeLKQ  
CFR Regulation Number866.3175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-05
Decision Date1997-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816784020444 K972884 000

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