ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)— 510(k) K032113

Name: FDA 510(k) clearance K032113
Creator: U.S. Food and Drug Administration
Published: 2003-12-23

Substantially Equivalent

Chroma Vision Medical Systems, Inc.

FDA 510(k) clearance K032113 for ACIS (AUTOMATED CELLULAR IMAGING SYSTEM), Substantially Equivalent on 2003-12-23. Applicant: Chroma Vision Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Chroma Vision Medical Systems, Inc.
Product code: Code NOT
Device class: Class 2
Regulation: 21 CFR 864.1860
Advisory panel: Hematology
Date received: 2003-07-09
Decision date: 2003-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NOT

view all

K260755 — OptraSCAN System2026-07-02
K141109 — APERIO EPATHOLOGY EIHC IVD SYSTEM2014-07-29
K121033 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)2013-09-06
K121350 — VIRTUSO SYSTEM FOR IHC (DO-7)2012-06-01
K111755 — VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)2012-02-22

More clearances from Chroma Vision Medical Systems, Inc.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.