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)

BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL

K-Number: K930267 · 1994-03-22

ApplicantBiomerieux Vitek, Inc.
Decision Date1994-03-22
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1994-03-22 under 510(k) number K930267. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL?

BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL is a medical device that received FDA 510(k) clearance on 1994-03-22. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K930267.

When did BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL receive FDA 510(k) clearance?

BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL received FDA 510(k) clearance on 1994-03-22, under 510(k) number K930267.

Who is the listed applicant for BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL?

The FDA 510(k) record lists Biomerieux Vitek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL?

The FDA product code for BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL is GGC.

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 Biomerieux Vitek, Inc. 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.

K973819VIDAS D-DIMER (DD) ASSAYK972895VIDAS ROTAVIRUS (RTV) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARD

View all 49 devices →

Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, 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.

↑