CIC-C1Q EIA— 510(k) K012576

Name: FDA 510(k) clearance K012576
Creator: U.S. Food and Drug Administration
Published: 2002-01-29

Substantially Equivalent

American Laboratory Products Co., Ltd.

FDA 510(k) clearance K012576 for CIC-C1Q EIA, Substantially Equivalent on 2002-01-29. Applicant: American Laboratory Products Co., Ltd.. Device class: 2.

Clearance details

Applicant: American Laboratory Products Co., Ltd.
Product code: Code DAK
Device class: Class 2
Regulation: 21 CFR 866.5240
Advisory panel: Immunology
Date received: 2001-08-09
Decision date: 2002-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, NH, US

Download summary PDF View on FDA.gov ↗

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