Cleared Traditional

K921570 - ORS-300
(FDA 510(k) Clearance)

K921570 · Mnlase, Inc. · Chemistry device

Jun 1992

Decision

68d

Days

Class 1

Risk

K921570 is an FDA 510(k) clearance for the ORS-300. This device is classified as a Freezer (Class I - General Controls, product code JRM).

Submitted by Mnlase, Inc. (Reston, US). The FDA issued a Cleared decision on June 9, 1992, 68 days after receiving the submission on April 2, 1992.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K921570 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 02, 1992
Decision Date	June 09, 1992
Days to Decision	68 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement