Cleared Traditional

K874897 - SAKURA DRS-60 AUTOMATIC SLIDE STAINER
(FDA 510(k) Clearance)

K874897 · Sakura Finetek U.S.A., Inc. · Pathology device

Jan 1988

Decision

35d

Days

Class 1

Risk

K874897 is an FDA 510(k) clearance for the SAKURA DRS-60 AUTOMATIC SLIDE STAINER. This device is classified as a Slide Stainer, Automated (Class I - General Controls, product code KPA).

Submitted by Sakura Finetek U.S.A., Inc. (Torrance, US). The FDA issued a Cleared decision on January 5, 1988, 35 days after receiving the submission on December 1, 1987.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3800.

Submission Details

510(k) Number	K874897 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 01, 1987
Decision Date	January 05, 1988
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—