GIARDIA STOOL ANTIGEN TEST KIT— 510(k) K890003

Name: FDA 510(k) clearance K890003
Creator: U.S. Food and Drug Administration
Published: 1989-03-14

Substantially Equivalent

Lmd Laboratories

FDA 510(k) clearance K890003 for GIARDIA STOOL ANTIGEN TEST KIT, Substantially Equivalent on 1989-03-14. Applicant: Lmd Laboratories. Device class: 2.

Clearance details

Applicant: Lmd Laboratories
Product code: Code KHW
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1989-01-03
Decision date: 1989-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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