AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101— 510(k) K072901

Name: FDA 510(k) clearance K072901
Creator: U.S. Food and Drug Administration
Published: 2008-07-01

Substantially Equivalent

Amdl, Inc.

FDA 510(k) clearance K072901 for AMDL-ELISA DR-70 (FDP) IMMUNOASSAY, MODEL DR2101, Substantially Equivalent on 2008-07-01. Applicant: Amdl, Inc.. Device class: 2.

Clearance details

Applicant: Amdl, Inc.
Product code: Code NTY
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2007-10-11
Decision date: 2008-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tustin, CA, US

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