COLORMATE TLC BILITEST SYSTEM— 510(k) K001687

Name: FDA 510(k) clearance K001687
Creator: U.S. Food and Drug Administration
Published: 2001-09-13

Substantially Equivalent

Chromatics Color Sciences Intl., Inc.

FDA 510(k) clearance K001687 for COLORMATE TLC BILITEST SYSTEM, Substantially Equivalent on 2001-09-13. Applicant: Chromatics Color Sciences Intl., Inc.. Device class: 1.

Clearance details

Applicant: Chromatics Color Sciences Intl., Inc.
Product code: Code MQM
Device class: Class 1
Regulation: 21 CFR 862.1113
Advisory panel: Clinical Chemistry
Date received: 2000-06-01
Decision date: 2001-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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