COLORMATE III— 510(k) K964590

Name: FDA 510(k) clearance K964590
Creator: U.S. Food and Drug Administration
Published: 1997-07-24

Substantially Equivalent

Chromatics Color Sciences Intl., Inc.

FDA 510(k) clearance K964590 for COLORMATE III, Substantially Equivalent on 1997-07-24. 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: 1996-11-15
Decision date: 1997-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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