AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)— 510(k) K984188

Name: FDA 510(k) clearance K984188
Creator: U.S. Food and Drug Administration
Published: 1999-07-28

Substantially Equivalent

Chroma Vision Medical Systems, Inc.

FDA 510(k) clearance K984188 for AUTOMATED CELLULAR IMAGING SYSTEM (ACIS), Substantially Equivalent on 1999-07-28. Applicant: Chroma Vision Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Chroma Vision Medical Systems, Inc.
Product code: Code JOY
Device class: Class 2
Regulation: 21 CFR 864.5260
Advisory panel: Hematology
Date received: 1998-11-23
Decision date: 1999-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flower Mound, TX, US

Download summary PDF View on FDA.gov ↗

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