Cleared Traditional

K861897 - UNISKAN II
(FDA 510(k) Clearance)

K861897 · Flow Laboratories, Inc. · Chemistry

Jul 1986

Decision

46d

Days

Class 1

Risk

K861897 is an FDA 510(k) clearance for the UNISKAN II, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Flow Laboratories, Inc. (Mclean, US). The FDA issued a Cleared decision on July 1, 1986, 46 days after receiving the submission on May 16, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number	K861897 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 16, 1986
Decision Date	July 01, 1986
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—