Cleared Traditional

MICROSTAT 2

K984485 · Chemlink Laboratories, LLC · General Hospital

Jan 1999

Decision

27d

Days

Class 1

Risk

About This 510(k) Submission

K984485 is an FDA 510(k) clearance for the MICROSTAT 2, a Disinfectant, Medical Devices (Class I — General Controls, product code LRJ), submitted by Chemlink Laboratories, LLC (Washington, US). The FDA issued a Cleared decision on January 13, 1999, 27 days after receiving the submission on December 17, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6890.

Submission Details

510(k) Number	K984485 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 1998
Decision Date	January 13, 1999
Days to Decision	27 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement