COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)

Complement C9, Antigen, Antiserum, Control

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Complement Activation Eia Test System (cae).

Pre-market Notification Details

Device IDK951639
510k NumberK951639
Device Name:COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)
ClassificationComplement C9, Antigen, Antiserum, Control
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactMary E Best
CorrespondentMary E Best
INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
Product CodeDAE  
CFR Regulation Number866.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-10
Decision Date1995-10-13

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