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FDA 510(k)

ACTICHROME HEPARIN (ANTI-FIIA)

K-Number: K013637 · 2002-04-16

ApplicantAmerican Diagnostica, Inc.
Decision Date2002-04-16
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTICHROME HEPARIN (ANTI-FIIA) is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostica, Inc.. It received FDA 510(k) clearance on 2002-04-16 under 510(k) number K013637. 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 ACTICHROME HEPARIN (ANTI-FIIA)?

ACTICHROME HEPARIN (ANTI-FIIA) is a medical device that received FDA 510(k) clearance on 2002-04-16. The listed applicant is American Diagnostica, Inc.. The 510(k) number is K013637.

When did ACTICHROME HEPARIN (ANTI-FIIA) receive FDA 510(k) clearance?

ACTICHROME HEPARIN (ANTI-FIIA) received FDA 510(k) clearance on 2002-04-16, under 510(k) number K013637.

Who is the listed applicant for ACTICHROME HEPARIN (ANTI-FIIA)?

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

What is the FDA product code for ACTICHROME HEPARIN (ANTI-FIIA)?

The FDA product code for ACTICHROME HEPARIN (ANTI-FIIA) is KFF.

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Other records listing American Diagnostica, 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.

K080069DIMERTESTK063323SPECTROLYSE PAI-1, MODEL 101201K052124ACTICLOT, MODEL 824K013492IMUBIND TPA ELISA, MODEL 860K013318ACTICHROME HEPARIN (ANTI-FXA), MODEL 832K013168IMUBIND PLASMA PAI-1 ELISA,MODEL 822

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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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