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FDA 510(k)

THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES

K-Number: K993678 · 2000-05-05

ApplicantHaemoscope Corp.
Decision Date2000-05-05
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Haemoscope Corp.. It received FDA 510(k) clearance on 2000-05-05 under 510(k) number K993678. 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 THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES?

THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES is a medical device that received FDA 510(k) clearance on 2000-05-05. The listed applicant is Haemoscope Corp.. The 510(k) number is K993678.

When did THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES receive FDA 510(k) clearance?

THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES received FDA 510(k) clearance on 2000-05-05, under 510(k) number K993678.

Who is the listed applicant for THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES?

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

What is the FDA product code for THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES?

The FDA product code for THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES is JPA.

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Other records listing Haemoscope Corp. 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.

K062604RAPIDTEG TEG-ACT TESTK041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAYK002177THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESK954437THROMBELASTOGRAPH COAGULATION ANALYZER 3000SK904204THROMBELASTOGRAPHK895844THROMBELASTOGRAPH(R)

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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

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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