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FDA 510(k)

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

K-Number: K111822 · 2011-10-26

ApplicantDiagnostica Stago, Inc.
Decision Date2011-10-26
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago, Inc.. It received FDA 510(k) clearance on 2011-10-26 under 510(k) number K111822. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH is a medical device that received FDA 510(k) clearance on 2011-10-26. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K111822.

When did STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH receive FDA 510(k) clearance?

STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH received FDA 510(k) clearance on 2011-10-26, under 510(k) number K111822.

Who is the listed applicant for STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH?

The FDA 510(k) record lists Diagnostica Stago, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH?

The FDA product code for STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH is KFF.

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Other records listing Diagnostica Stago, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260214STA® - Liquid Anti-XaK253658STA Satellite Max®K120014STA- COAG CONTROL (N+ABN) PLUSK092937STA-HYBRID HEP CALIBRATORK093167STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZERK092170STA LIATEST FREE PS

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Related Devices (Code: KFF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen BiomedK013305ENOXAPARIN TEST CARDCardiovascular Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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