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FDA 510(k)

CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL

K-Number: K902081 · 1990-07-03

ApplicantHemotec, Inc.
Decision Date1990-07-03
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Hemotec, Inc.. It received FDA 510(k) clearance on 1990-07-03 under 510(k) number K902081. 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 CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL?

CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL is a medical device that received FDA 510(k) clearance on 1990-07-03. The listed applicant is Hemotec, Inc.. The 510(k) number is K902081.

When did CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL receive FDA 510(k) clearance?

CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL received FDA 510(k) clearance on 1990-07-03, under 510(k) number K902081.

Who is the listed applicant for CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL?

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

What is the FDA product code for CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL?

The FDA product code for CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL is JBP.

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Other records listing Hemotec, 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.

K894317HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.K894359CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLSK894466HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLSK884590HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGESK875089HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARINK880302CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER

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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

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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