ORGENTEC MICRO-ALBUMIN EIA ASSAY— 510(k) K970932

Name: FDA 510(k) clearance K970932
Creator: U.S. Food and Drug Administration
Published: 1997-04-08

Substantially Equivalent

American Laboratory Products Co., Ltd.

FDA 510(k) clearance K970932 for ORGENTEC MICRO-ALBUMIN EIA ASSAY, Substantially Equivalent on 1997-04-08. Applicant: American Laboratory Products Co., Ltd.. Device class: 1.

Clearance details

Applicant: American Laboratory Products Co., Ltd.
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1997-02-20
Decision date: 1997-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

Download summary PDF View on FDA.gov ↗

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