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FDA 510(k)

HEMOCHRON(R) HEPARIN RESPONSE TEST

K-Number: K904003 · 1990-11-29

ApplicantIntensive Technology, Inc.
Decision Date1990-11-29
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON(R) HEPARIN RESPONSE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Intensive Technology, Inc.. It received FDA 510(k) clearance on 1990-11-29 under 510(k) number K904003. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHRON(R) HEPARIN RESPONSE TEST?

HEMOCHRON(R) HEPARIN RESPONSE TEST is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Intensive Technology, Inc.. The 510(k) number is K904003.

When did HEMOCHRON(R) HEPARIN RESPONSE TEST receive FDA 510(k) clearance?

HEMOCHRON(R) HEPARIN RESPONSE TEST received FDA 510(k) clearance on 1990-11-29, under 510(k) number K904003.

Who is the listed applicant for HEMOCHRON(R) HEPARIN RESPONSE TEST?

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

What is the FDA product code for HEMOCHRON(R) HEPARIN RESPONSE TEST?

The FDA product code for HEMOCHRON(R) HEPARIN RESPONSE TEST is KFF.

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Other records listing Intensive Technology, 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.

K922970INTRA-OPERATIVE TEC ATHERECTOMY SYSTEMK912664TEC ROTATING DUAL HEMOVALVEK911869IVT GUIDING CATHETERK903463IVT INTRODUCER SHEATHK901767MODIFIED IVT PERIPHERAL ATHERECTOMYK896403MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM

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Related Devices (Code: KFF)

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.

K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed

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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