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FDA 510(k)

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER

K-Number: K952560 · 1995-09-05

ApplicantSienco, Inc.
Decision Date1995-09-05
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Sienco, Inc.. It received FDA 510(k) clearance on 1995-09-05 under 510(k) number K952560. 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 SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER?

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER is a medical device that received FDA 510(k) clearance on 1995-09-05. The listed applicant is Sienco, Inc.. The 510(k) number is K952560.

When did SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER receive FDA 510(k) clearance?

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER received FDA 510(k) clearance on 1995-09-05, under 510(k) number K952560.

Who is the listed applicant for SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER?

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

What is the FDA product code for SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER?

The FDA product code for SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER is JPA.

Related Clinical Trials

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.

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Other records listing Sienco, 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.

K223635Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerK032952AIACT KITK002528SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTIONK984141GBACT + KIT

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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