Cleared Traditional

K915427 - ORS-1000
(FDA 510(k) Clearance)

K915427 · Mnlase, Inc. · Chemistry device

Jan 1992

Decision

36d

Days

Class 1

Risk

K915427 is an FDA 510(k) clearance for the ORS-1000. 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 January 7, 1992, 36 days after receiving the submission on December 2, 1991.

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

Submission Details

510(k) Number	K915427 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 02, 1991
Decision Date	January 07, 1992
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement