E. COLI 0157 ELISA STOOL ASSAY— 510(k) K942705

Name: FDA 510(k) clearance K942705
Creator: U.S. Food and Drug Administration
Published: 1995-09-27

Substantially Equivalent

Lmd Laboratories

FDA 510(k) clearance K942705 for E. COLI 0157 ELISA STOOL ASSAY, Substantially Equivalent on 1995-09-27. Applicant: Lmd Laboratories. Device class: 1.

Clearance details

Applicant: Lmd Laboratories
Product code: Code GMZ
Device class: Class 1
Regulation: 21 CFR 866.3255
Advisory panel: Microbiology
Date received: 1994-06-08
Decision date: 1995-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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