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FDA 510(k)

THROMBELASTOGRAPH(R)

K-Number: K895844 · 1989-10-24

ApplicantHaemoscope Corp.
Decision Date1989-10-24
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

THROMBELASTOGRAPH(R) is the device name listed in this FDA 510(k) record. The listed applicant is Haemoscope Corp.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K895844. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THROMBELASTOGRAPH(R)?

THROMBELASTOGRAPH(R) is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Haemoscope Corp.. The 510(k) number is K895844.

When did THROMBELASTOGRAPH(R) receive FDA 510(k) clearance?

THROMBELASTOGRAPH(R) received FDA 510(k) clearance on 1989-10-24, under 510(k) number K895844.

Who is the listed applicant for THROMBELASTOGRAPH(R)?

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(R)?

The FDA product code for THROMBELASTOGRAPH(R) is GKP.

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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 SERIESK993678THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIESK954437THROMBELASTOGRAPH COAGULATION ANALYZER 3000SK904204THROMBELASTOGRAPH

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Related Devices (Code: GKP)

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.

K242127ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)Instrumentation Laboratory (IL) Co.K231031ACL TOP Family 70 SeriesInstrumentation Laboratory CompanyK160276ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)Instrumentation Laboratory COK091980ACL TOP 700 LASInstrumentation Laboratory COK073377ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)Instrumentation Laboratory COK063679ACL TOPInstrumentation Laboratory CO

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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