STA- COAG CONTROL (N+ABN) PLUS

Plasma, Coagulation Control

DIAGNOSTICA STAGO, INC.

The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta- Coag Control (n+abn) Plus.

Pre-market Notification Details

Device IDK120014
510k NumberK120014
Device Name:STA- COAG CONTROL (N+ABN) PLUS
ClassificationPlasma, Coagulation Control
Applicant DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany,  NJ  07054
ContactKevin Wyckoff
CorrespondentKevin Wyckoff
DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany,  NJ  07054
Product CodeGGN  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-29
Decision Date2013-03-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03607450006773 K120014 000

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