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FDA 510(k)

E. COLI 0157 ELISA STOOL ASSAY

K-Number: K942705 · 1995-09-27

ApplicantLmd Laboratories
Decision Date1995-09-27
Product CodeGMZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

E. COLI 0157 ELISA STOOL ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Lmd Laboratories. It received FDA 510(k) clearance on 1995-09-27 under 510(k) number K942705. 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 E. COLI 0157 ELISA STOOL ASSAY?

E. COLI 0157 ELISA STOOL ASSAY is a medical device that received FDA 510(k) clearance on 1995-09-27. The listed applicant is Lmd Laboratories. The 510(k) number is K942705.

When did E. COLI 0157 ELISA STOOL ASSAY receive FDA 510(k) clearance?

E. COLI 0157 ELISA STOOL ASSAY received FDA 510(k) clearance on 1995-09-27, under 510(k) number K942705.

Who is the listed applicant for E. COLI 0157 ELISA STOOL ASSAY?

The FDA 510(k) record lists Lmd Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E. COLI 0157 ELISA STOOL ASSAY?

The FDA product code for E. COLI 0157 ELISA STOOL ASSAY is GMZ.

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Other records listing Lmd Laboratories 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.

K955345LMD CRYPTOSPORIDIUM ANTIGEN DETECTIONK944871LMD GIARDIA ANTIGEN DETECTION ASSAYK905598CRYPTOSPORIDIUM ANTIGEN DETECTIONK904613TRICHINELLA SEROLOGY MICROTITER ELISAK900780CYSTICERCOSIS SEROLOGICAL REAGENTSK890003GIARDIA STOOL ANTIGEN TEST KIT

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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.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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