STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH

Assay, Heparin

DIAGNOSTICA STAGO, INC.

The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta(r) - Liquid Anti-xa, Multi Hep Calibrator, Quality Hnf / Ufh, Quality Hbpm / Lmwh.

Pre-market Notification Details

Device IDK111822
510k NumberK111822
Device Name:STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
ClassificationAssay, Heparin
Applicant DIAGNOSTICA STAGO, INC. PIAZZA ALBANIA, 10 Rome,  IT 00153
ContactCarlo D'alessandro
CorrespondentCarlo D'alessandro
DIAGNOSTICA STAGO, INC. PIAZZA ALBANIA, 10 Rome,  IT 00153
Product CodeKFF  
Subsequent Product CodeGGN
Subsequent Product CodeJIS
CFR Regulation Number864.7525 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-28
Decision Date2011-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03607450011784 K111822 000
03607450011791 K111822 000
03607450003819 K111822 000
03607450003482 K111822 000

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