Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA

K-Number: K973628 · 1998-03-13

ApplicantVital Scientific N.V.
Decision Date1998-03-13
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA 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 1998-03-13 under 510(k) number K973628. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA?

VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Vital Scientific N.V.. The 510(k) number is K973628.

When did VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA receive FDA 510(k) clearance?

VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA received FDA 510(k) clearance on 1998-03-13, under 510(k) number K973628.

Who is the listed applicant for VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA?

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 VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA?

The FDA product code for VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA is JJF.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 CONTROLK020840VITAL SCIENTIFIC PT WITH CALCIUM

Related Devices (Code: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, Inc.

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.

↑