DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT— 510(k) K963525

Name: FDA 510(k) clearance K963525
Creator: U.S. Food and Drug Administration
Published: 1996-11-07

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K963525 for DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT, Substantially Equivalent on 1996-11-07. Applicant: Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code DBL
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 1996-09-04
Decision date: 1996-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dundee, GB

Download summary PDF View on FDA.gov ↗

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