Cleared Traditional

K935316 - PARASAFE(R) FIXATIVE
(FDA 510(k) Clearance)

K935316 · Scientific Device Laboratory, Inc. · Microbiology device

Feb 1994

Decision

107d

Days

Class 1

Risk

K935316 is an FDA 510(k) clearance for the PARASAFE(R) FIXATIVE. This device is classified as a Device, Parasite Concentration (Class I - General Controls, product code LKS).

Submitted by Scientific Device Laboratory, Inc. (Glenview, US). The FDA issued a Cleared decision on February 17, 1994, 107 days after receiving the submission on November 2, 1993.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number	K935316 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 02, 1993
Decision Date	February 17, 1994
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement