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FDA 510(k)

VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL

K-Number: K022046 · 2002-07-23

ApplicantVital Scientific N.V.
Decision Date2002-07-23
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Vital Scientific N.V.. It received FDA 510(k) clearance on 2002-07-23 under 510(k) number K022046. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL?

VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL is a medical device that received FDA 510(k) clearance on 2002-07-23. The listed applicant is Vital Scientific N.V.. The 510(k) number is K022046.

When did VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL receive FDA 510(k) clearance?

VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL received FDA 510(k) clearance on 2002-07-23, under 510(k) number K022046.

Who is the listed applicant for VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL?

The FDA 510(k) record lists Vital Scientific N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL?

The FDA product code for VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL is GGN.

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Other records listing Vital Scientific N.V. 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.

K022021VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTTK021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONK020840VITAL SCIENTIFIC PT WITH CALCIUMK973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA

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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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