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FDA 510(k)

ACTICHROME HEPARIN (ANTI-FXA), MODEL 832

K-Number: K013318 · 2002-03-08

ApplicantAmerican Diagnostica, Inc.
Decision Date2002-03-08
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 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 2002-03-08 under 510(k) number K013318. 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-FXA), MODEL 832?

ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is American Diagnostica, Inc.. The 510(k) number is K013318.

When did ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 receive FDA 510(k) clearance?

ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 received FDA 510(k) clearance on 2002-03-08, under 510(k) number K013318.

Who is the listed applicant for ACTICHROME HEPARIN (ANTI-FXA), MODEL 832?

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-FXA), MODEL 832?

The FDA product code for ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 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 824K013637ACTICHROME HEPARIN (ANTI-FIIA)K013492IMUBIND TPA ELISA, MODEL 860K013168IMUBIND 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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