IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25— 510(k) K022538

Name: FDA 510(k) clearance K022538
Creator: U.S. Food and Drug Administration
Published: 2002-08-23

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K022538 for IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25, Substantially Equivalent on 2002-08-23. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 2002-08-01
Decision date: 2002-08-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Laguna Hills, CA, US

Download summary PDF View on FDA.gov ↗

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