Cleared Traditional

IDS RAPID SS/U SYSTEM

K852871 · Innovative Diagnostic Systems, Inc. · Microbiology

Jul 1985

Decision

15d

Days

Class 1

Risk

About This 510(k) Submission

K852871 is an FDA 510(k) clearance for the IDS RAPID SS/U SYSTEM, a Kit, Identification, Enterobacteriaceae (Class I — General Controls, product code JSS), submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on July 23, 1985, 15 days after receiving the submission on July 8, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K852871 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 1985
Decision Date	July 23, 1985
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—