Cleared Traditional

CRYOBIOLOGICAL FREEZER

K881465 · Cryodyne Technologies, Inc. · Pathology

Apr 1988

Decision

15d

Days

Class 1

Risk

About This 510(k) Submission

K881465 is an FDA 510(k) clearance for the CRYOBIOLOGICAL FREEZER, a Apparatus, Cell-freezing And Reagents (Class I — General Controls, product code KSP), submitted by Cryodyne Technologies, Inc. (Soquel, US). The FDA issued a Cleared decision on April 21, 1988, 15 days after receiving the submission on April 6, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.9225.

Submission Details

510(k) Number	K881465 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 06, 1988
Decision Date	April 21, 1988
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—