Cleared Traditional

MICROSCOPE STAGE HEATER

K881467 · Cryodyne Technologies, Inc. · Pathology
Apr 1988
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K881467 is an FDA 510(k) clearance for the MICROSCOPE STAGE HEATER, a Stages, Microscope (Class I — General Controls, product code KEJ), submitted by Cryodyne Technologies, Inc. (Soquel, US). The FDA issued a Cleared decision on April 18, 1988, 12 days after receiving the submission on April 6, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3600.

Submission Details

510(k) Number K881467 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 1988
Decision Date April 18, 1988
Days to Decision 12 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KEJ — Stages, Microscope
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3600