Cleared Traditional

K092346 - SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171
(FDA 510(k) Clearance)

K092346 · Serim Research Corp. · General Hospital

Jan 2010

Decision

156d

Days

Class 2

Risk

K092346 is an FDA 510(k) clearance for the SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171, a Indicator, Physical/chemical Sterilization Process (Class II — Special Controls, product code JOJ), submitted by Serim Research Corp. (Elkhart, US). The FDA issued a Cleared decision on January 7, 2010, 156 days after receiving the submission on August 4, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number	K092346 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2009
Decision Date	January 07, 2010
Days to Decision	156 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF