Cleared Traditional

K882881 - SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER
(FDA 510(k) Clearance)

K882881 · Sakura Finetek U.S.A., Inc. · Pathology

Jul 1988

Decision

17d

Days

Class 1

Risk

K882881 is an FDA 510(k) clearance for the SAKURA-MEDSCAND SCA-1800 AUTOMATIC COVERSLIPPER. This device is classified as a Coverslips, Microscope Slide (Class I — General Controls, product code KES).

Submitted by Sakura Finetek U.S.A., Inc. (Torrance, US). The FDA issued a Cleared decision on July 28, 1988, 17 days after receiving the submission on July 11, 1988.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3010.

Submission Details

510(k) Number	K882881 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 1988
Decision Date	July 28, 1988
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—