Cleared Traditional

CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE

K881922 · Surgipath Medical Industries, Inc. · Pathology

May 1988

Decision

16d

Days

Class 1

Risk

About This 510(k) Submission

K881922 is an FDA 510(k) clearance for the CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE, a Fixative, Alcohol Containing (Class I — General Controls, product code LDZ), submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on May 25, 1988, 16 days after receiving the submission on May 9, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K881922 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 1988
Decision Date	May 25, 1988
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—