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FDA 510(k)

ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN

K-Number: K010455 · 2001-06-07

ApplicantDiagnostica-Stago
Decision Date2001-06-07
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica-Stago. It received FDA 510(k) clearance on 2001-06-07 under 510(k) number K010455. 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 ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN?

ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN is a medical device that received FDA 510(k) clearance on 2001-06-07. The listed applicant is Diagnostica-Stago. The 510(k) number is K010455.

When did ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN receive FDA 510(k) clearance?

ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN received FDA 510(k) clearance on 2001-06-07, under 510(k) number K010455.

Who is the listed applicant for ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN?

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

What is the FDA product code for ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN?

The FDA product code for ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN is KFF.

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Other records listing Diagnostica-Stago as applicant

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K162227STA® - Liatest® D-Di

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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