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FDA 510(k)

VITAL SCIENTIFIC PT WITH CALCIUM

K-Number: K020840 · 2002-05-15

ApplicantVital Scientific N.V.
Decision Date2002-05-15
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VITAL SCIENTIFIC PT WITH CALCIUM 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 2002-05-15 under 510(k) number K020840. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITAL SCIENTIFIC PT WITH CALCIUM?

VITAL SCIENTIFIC PT WITH CALCIUM is a medical device that received FDA 510(k) clearance on 2002-05-15. The listed applicant is Vital Scientific N.V.. The 510(k) number is K020840.

When did VITAL SCIENTIFIC PT WITH CALCIUM receive FDA 510(k) clearance?

VITAL SCIENTIFIC PT WITH CALCIUM received FDA 510(k) clearance on 2002-05-15, under 510(k) number K020840.

Who is the listed applicant for VITAL SCIENTIFIC PT WITH CALCIUM?

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 PT WITH CALCIUM?

The FDA product code for VITAL SCIENTIFIC PT WITH CALCIUM is GJS.

Related Clinical Trials

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.

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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, FIBRONK022046VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROLK973628VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA

Related Devices (Code: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

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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