HUMAN LYME IGM WESTERN BLOT KIT— 510(k) K970768

Name: FDA 510(k) clearance K970768
Creator: U.S. Food and Drug Administration
Published: 1998-04-09

Substantially Equivalent

Cambridge Diagnostics Ireland, Ltd.

FDA 510(k) clearance K970768 for HUMAN LYME IGM WESTERN BLOT KIT, Substantially Equivalent on 1998-04-09. Applicant: Cambridge Diagnostics Ireland, Ltd.. Device class: 2.

Clearance details

Applicant: Cambridge Diagnostics Ireland, Ltd.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1997-03-03
Decision date: 1998-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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