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)

WELLCOLEX E.COLI O157:H7

K-Number: K971663 · 1997-12-30

ApplicantMurex Biotech , Ltd.
Decision Date1997-12-30
Product CodeGMZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WELLCOLEX E.COLI O157:H7 is the device name listed in this FDA 510(k) record. The listed applicant is Murex Biotech , Ltd.. It received FDA 510(k) clearance on 1997-12-30 under 510(k) number K971663. The device is classified under product code GMZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELLCOLEX E.COLI O157:H7?

WELLCOLEX E.COLI O157:H7 is a medical device that received FDA 510(k) clearance on 1997-12-30. The listed applicant is Murex Biotech , Ltd.. The 510(k) number is K971663.

When did WELLCOLEX E.COLI O157:H7 receive FDA 510(k) clearance?

WELLCOLEX E.COLI O157:H7 received FDA 510(k) clearance on 1997-12-30, under 510(k) number K971663.

Who is the listed applicant for WELLCOLEX E.COLI O157:H7?

The FDA 510(k) record lists Murex Biotech , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WELLCOLEX E.COLI O157:H7?

The FDA product code for WELLCOLEX E.COLI O157:H7 is GMZ.

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

Related Devices (Code: GMZ)

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.

K222829Curian® Shiga ToxinMeridian Bioscience, Inc.K121364SHIGA TOXIN QUIK CHEKTechlab Inc., Corporate Research CenterK121411SHIGA TOXIN CHEKTechlab Inc., Corporate Research CenterK062546IMMUNOCARD STAT! EHEC, MODEL 751630Meridian Bioscience, Inc.K061889BIOSTAR OIA SHIGATOXInverness Medical-Biostar, Inc.K023599IMMUNOCARD STAT! E. COLI O157 PLUSMeridian Bioscience, 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.

↑