DIASTAT ENA PROFILE— 510(k) K905190

Substantially Equivalent

Shield Diagnostics, Ltd.

FDA 510(k) clearance K905190 for DIASTAT ENA PROFILE, Substantially Equivalent on 1990-12-07. Applicant: Shield Diagnostics, Ltd.. Device class: 2.

Clearance details

Applicant: Shield Diagnostics, Ltd.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1990-11-19
Decision date: 1990-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scotland, KN

Download summary PDF View on FDA.gov ↗

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