THE INTUITIVE COLORIMETER— 510(k) K012298

Name: FDA 510(k) clearance K012298
Creator: U.S. Food and Drug Administration
Published: 2001-09-26

Substantially Equivalent

Cerium Optical Technologies, Inc.

FDA 510(k) clearance K012298 for THE INTUITIVE COLORIMETER, Substantially Equivalent on 2001-09-26. Applicant: Cerium Optical Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Cerium Optical Technologies, Inc.
Product code: Code NFD
Device class: Class 1
Regulation: 21 CFR 886.1160
Advisory panel: Ophthalmic
Date received: 2001-07-20
Decision date: 2001-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

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