Cleared Traditional

IDS RAPID CB PLUS SYSTEM

K962966 · Innovative Diagnostic Systems, Inc. · Microbiology

Oct 1996

Decision

70d

Days

Class 1

Risk

About This 510(k) Submission

K962966 is an FDA 510(k) clearance for the IDS RAPID CB PLUS SYSTEM, a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO), submitted by Innovative Diagnostic Systems, Inc. (Norcross, US). The FDA issued a Cleared decision on October 8, 1996, 70 days after receiving the submission on July 30, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K962966 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 30, 1996
Decision Date	October 08, 1996
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement