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FDA 510(k)

BIOSTAR OIA SHIGATOX

K-Number: K061889 · 2006-12-12

ApplicantInverness Medical-Biostar, Inc.
Decision Date2006-12-12
Product CodeGMZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOSTAR OIA SHIGATOX is the device name listed in this FDA 510(k) record. The listed applicant is Inverness Medical-Biostar, Inc.. It received FDA 510(k) clearance on 2006-12-12 under 510(k) number K061889. 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 BIOSTAR OIA SHIGATOX?

BIOSTAR OIA SHIGATOX is a medical device that received FDA 510(k) clearance on 2006-12-12. The listed applicant is Inverness Medical-Biostar, Inc.. The 510(k) number is K061889.

When did BIOSTAR OIA SHIGATOX receive FDA 510(k) clearance?

BIOSTAR OIA SHIGATOX received FDA 510(k) clearance on 2006-12-12, under 510(k) number K061889.

Who is the listed applicant for BIOSTAR OIA SHIGATOX?

The FDA 510(k) record lists Inverness Medical-Biostar, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSTAR OIA SHIGATOX?

The FDA product code for BIOSTAR OIA SHIGATOX is GMZ.

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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.K121411SHIGA TOXIN CHEKTechlab Inc., Corporate Research CenterK121364SHIGA TOXIN QUIK CHEKTechlab Inc., Corporate Research CenterK062546IMMUNOCARD STAT! EHEC, MODEL 751630Meridian Bioscience, Inc.K023599IMMUNOCARD STAT! E. COLI O157 PLUSMeridian Bioscience, Inc.K990263IMMUNOCARD STAT! E. COLI O157:H7Meridian Diagnostics, 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.

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