DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA— 510(k) K972337

Name: FDA 510(k) clearance K972337
Creator: U.S. Food and Drug Administration
Published: 1997-08-08

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K972337 for DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA, Substantially Equivalent on 1997-08-08. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1997-06-23
Decision date: 1997-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E.I., CA

Download summary PDF View on FDA.gov ↗

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