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FDA 510(k)

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY

K-Number: K041502 · 2004-09-01

ApplicantHaemoscope Corp.
Decision Date2004-09-01
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Haemoscope Corp.. It received FDA 510(k) clearance on 2004-09-01 under 510(k) number K041502. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY?

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY is a medical device that received FDA 510(k) clearance on 2004-09-01. The listed applicant is Haemoscope Corp.. The 510(k) number is K041502.

When did THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY receive FDA 510(k) clearance?

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY received FDA 510(k) clearance on 2004-09-01, under 510(k) number K041502.

Who is the listed applicant for THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY?

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 (TEG) PLATELET MAPPING ASSAY?

The FDA product code for THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY is JOZ.

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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 TESTK002177THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIESK993678THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIESK954437THROMBELASTOGRAPH COAGULATION ANALYZER 3000SK904204THROMBELASTOGRAPHK895844THROMBELASTOGRAPH(R)

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Related Devices (Code: JOZ)

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.

K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01Fujimori Kogyo, Co., Ltd.K181777AggreGuide A-100 ADPAggredyne, Inc.K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc.K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp.K122162AGGREGUIDEAggredyne, Inc.K103555MULTIPLATE 5.0 AGGREGOMETERVerum Diagnostica GmbH

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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