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FDA 510(k)

ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA

K-Number: K903841 · 1990-10-22

ApplicantOrganon Teknika Corp.
Decision Date1990-10-22
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1990-10-22 under 510(k) number K903841. 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 ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA?

ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA is a medical device that received FDA 510(k) clearance on 1990-10-22. The listed applicant is Organon Teknika Corp.. The 510(k) number is K903841.

When did ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA receive FDA 510(k) clearance?

ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA received FDA 510(k) clearance on 1990-10-22, under 510(k) number K903841.

Who is the listed applicant for ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA?

The FDA product code for ORGANON TEKNIDA CHROMOSTRAE (TM) HEPARIN ANTI-XA is KFF.

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Other records listing Organon Teknika Corp. 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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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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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