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FDA 510(k)

VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT

K-Number: K022021 · 2002-11-01

ApplicantVital Scientific N.V.
Decision Date2002-11-01
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT 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 2002-11-01 under 510(k) number K022021. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT?

VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT is a medical device that received FDA 510(k) clearance on 2002-11-01. The listed applicant is Vital Scientific N.V.. The 510(k) number is K022021.

When did VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT receive FDA 510(k) clearance?

VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT received FDA 510(k) clearance on 2002-11-01, under 510(k) number K022021.

Who is the listed applicant for VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT?

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 APTT, APTT & QUIKCOAG APTT?

The FDA product code for VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT is GFO.

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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.

K021976FIBRON-1, FIBRON-4, QUIKCOAG, FIBRONK022046VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROLK020840VITAL SCIENTIFIC PT WITH CALCIUMK973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA

Related Devices (Code: GFO)

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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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