Cleared Traditional

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

K111822 · Diagnostica Stago, Inc. · Hematology
Oct 2011
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K111822 is an FDA 510(k) clearance for the STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH, a Assay, Heparin (Class II — Special Controls, product code KFF), submitted by Diagnostica Stago, Inc. (Rome, IT). The FDA issued a Cleared decision on October 26, 2011, 120 days after receiving the submission on June 28, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7525.

Submission Details

510(k) Number K111822 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2011
Decision Date October 26, 2011
Days to Decision 120 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code KFF — Assay, Heparin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7525

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