FORESIGHT U120 URINE ANALYZER— 510(k) K120124

Name: FDA 510(k) clearance K120124
Creator: U.S. Food and Drug Administration
Published: 2012-03-06

Substantially Equivalent

ACON Laboratories, Inc.

FDA 510(k) clearance K120124 for FORESIGHT U120 URINE ANALYZER, Substantially Equivalent on 2012-03-06. Applicant: ACON Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: ACON Laboratories, Inc.
Product code: Code JIL
Device class: Class 2
Regulation: 21 CFR 862.1340
Advisory panel: Clinical Chemistry
Date received: 2012-01-17
Decision date: 2012-03-06
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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