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FDA 510(k)

QUIX RAPID E. COLI O157 STRIP TEST

K-Number: K972156 · 1997-10-16

ApplicantGuardian Scientific, Corp.
Decision Date1997-10-16
Product CodeGMZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUIX RAPID E. COLI O157 STRIP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Guardian Scientific, Corp.. It received FDA 510(k) clearance on 1997-10-16 under 510(k) number K972156. 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 QUIX RAPID E. COLI O157 STRIP TEST?

QUIX RAPID E. COLI O157 STRIP TEST is a medical device that received FDA 510(k) clearance on 1997-10-16. The listed applicant is Guardian Scientific, Corp.. The 510(k) number is K972156.

When did QUIX RAPID E. COLI O157 STRIP TEST receive FDA 510(k) clearance?

QUIX RAPID E. COLI O157 STRIP TEST received FDA 510(k) clearance on 1997-10-16, under 510(k) number K972156.

Who is the listed applicant for QUIX RAPID E. COLI O157 STRIP TEST?

The FDA 510(k) record lists Guardian Scientific, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUIX RAPID E. COLI O157 STRIP TEST?

The FDA product code for QUIX RAPID E. COLI O157 STRIP TEST is GMZ.

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Other records listing Guardian Scientific, Corp. 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.

K954994TRUSTK954995QUIX RAPID CHOLERA STRIP TESTK954993QUIX RAPID PREGNANCY STRIP TEST

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.

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