LMD GIARDIA ANTIGEN DETECTION ASSAY— 510(k) K944871

Name: FDA 510(k) clearance K944871
Creator: U.S. Food and Drug Administration
Published: 1995-06-22

Substantially Equivalent

Lmd Laboratories

FDA 510(k) clearance K944871 for LMD GIARDIA ANTIGEN DETECTION ASSAY, Substantially Equivalent on 1995-06-22. Applicant: Lmd Laboratories. Device class: 2.

Clearance details

Applicant: Lmd Laboratories
Product code: Code MHI
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1994-10-03
Decision date: 1995-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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