Cleared Traditional

CELL-CULTURE SHAKER

K881466 · Cryodyne Technologies, Inc. · Pathology

Apr 1988

Decision

12d

Days

Class 1

Risk

About This 510(k) Submission

K881466 is an FDA 510(k) clearance for the CELL-CULTURE SHAKER, a Apparatus, Roller (Class I — General Controls, product code KJB), 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 864.2240.

Submission Details

510(k) Number	K881466 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	—