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FDA 510(k)

SHIGA TOXIN CHEK

K-Number: K121411 · 2012-10-02

ApplicantTechlab Inc., Corporate Research Center
Decision Date2012-10-02
Product CodeGMZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SHIGA TOXIN CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Techlab Inc., Corporate Research Center. It received FDA 510(k) clearance on 2012-10-02 under 510(k) number K121411. 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 SHIGA TOXIN CHEK?

SHIGA TOXIN CHEK is a medical device that received FDA 510(k) clearance on 2012-10-02. The listed applicant is Techlab Inc., Corporate Research Center. The 510(k) number is K121411.

When did SHIGA TOXIN CHEK receive FDA 510(k) clearance?

SHIGA TOXIN CHEK received FDA 510(k) clearance on 2012-10-02, under 510(k) number K121411.

Who is the listed applicant for SHIGA TOXIN CHEK?

The FDA 510(k) record lists Techlab Inc., Corporate Research Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHIGA TOXIN CHEK?

The FDA product code for SHIGA TOXIN CHEK is GMZ.

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Other records listing Techlab Inc., Corporate Research Center 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.

K121364SHIGA TOXIN QUIK CHEKK103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKK071712LEUKO EZ VUEK071711ASCA-CHEK

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 CenterK062546IMMUNOCARD STAT! EHEC, MODEL 751630Meridian Bioscience, Inc.K061889BIOSTAR OIA SHIGATOXInverness Medical-Biostar, 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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