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FDA 510(k)

STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER

K-Number: K093001 · 2009-12-18

ApplicantDiagnostica Stago, Incorporated
Decision Date2009-12-18
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago, Incorporated. It received FDA 510(k) clearance on 2009-12-18 under 510(k) number K093001. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER?

STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER is a medical device that received FDA 510(k) clearance on 2009-12-18. The listed applicant is Diagnostica Stago, Incorporated. The 510(k) number is K093001.

When did STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER receive FDA 510(k) clearance?

STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER received FDA 510(k) clearance on 2009-12-18, under 510(k) number K093001.

Who is the listed applicant for STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER?

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

What is the FDA product code for STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER?

The FDA product code for STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER is JPA.

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Other records listing Diagnostica Stago, Incorporated 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.

K130090STA COMPACT MAX

Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

Official Source

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

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