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510(k) K984188

AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) by Chroma Vision Medical Systems, Inc. — Product Code JOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1999
Date Received
November 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Cell-Locating
Device Class
Class II
Regulation Number
864.5260
Review Panel
HE
Submission Type

Other clearances by Chroma Vision Medical Systems, Inc.

  • K032113 — ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (December 23, 2003)
  • K012138 — MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) (September 30, 2002)

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