Cleared Traditional

K874750 - VIDEO ANALYZER 4000 (FDA 510(k) Clearance)

Apr 1988
Decision
159d
Days
Class 1
Risk

K874750 is an FDA 510(k) clearance for the VIDEO ANALYZER 4000. This device is classified as a Light, Microscope (Class I - General Controls, product code IBJ).

Submitted by Scientific Imaging, Inc. (Fairfield, US). The FDA issued a Cleared decision on April 25, 1988, 159 days after receiving the submission on November 18, 1987.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3600.

Submission Details

510(k) Number K874750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date April 25, 1988
Days to Decision 159 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary

Device Classification

Product Code IBJ — Light, Microscope
Device Class Class I - General Controls
CFR Regulation 21 CFR 864.3600

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