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FDA 510(k)

HEMOTEC ACT I SYSTEM

K-Number: K843459 · 1984-12-12

ApplicantHemotec, Inc.
Decision Date1984-12-12
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOTEC ACT I SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hemotec, Inc.. It received FDA 510(k) clearance on 1984-12-12 under 510(k) number K843459. 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 HEMOTEC ACT I SYSTEM?

HEMOTEC ACT I SYSTEM is a medical device that received FDA 510(k) clearance on 1984-12-12. The listed applicant is Hemotec, Inc.. The 510(k) number is K843459.

When did HEMOTEC ACT I SYSTEM receive FDA 510(k) clearance?

HEMOTEC ACT I SYSTEM received FDA 510(k) clearance on 1984-12-12, under 510(k) number K843459.

Who is the listed applicant for HEMOTEC ACT I SYSTEM?

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 HEMOTEC ACT I SYSTEM?

The FDA product code for HEMOTEC ACT I SYSTEM 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.

K902081CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROLK894359CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLSK894317HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.K894466HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLSK884590HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGESK875089HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN

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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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