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FDA 510(k)

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION

K-Number: K002528 · 2000-08-31

ApplicantSienco, Inc.
Decision Date2000-08-31
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Sienco, Inc.. It received FDA 510(k) clearance on 2000-08-31 under 510(k) number K002528. The device is classified under product code JBP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION?

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION is a medical device that received FDA 510(k) clearance on 2000-08-31. The listed applicant is Sienco, Inc.. The 510(k) number is K002528.

When did SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION receive FDA 510(k) clearance?

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION received FDA 510(k) clearance on 2000-08-31, under 510(k) number K002528.

Who is the listed applicant for SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION?

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 SYSTEM WITH SIGNATURE VIEWER OPTION?

The FDA product code for SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION is JBP.

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 KITK984141GBACT + KITK952560SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER

Related Devices (Code: JBP)

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 ViewerSienco, Inc.K062604RAPIDTEG TEG-ACT TESTHaemoscope Corp.K032952AIACT KITSienco, Inc.K023582I-STAT KAOLIN ACT TESTI-Stat CorporationK020914ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770Helena LaboratoriesK013078ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752Helena Laboratories

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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