Cleared Traditional

IDS RAPID ANA SYSTEM

K882960 · Innovative Diagnostic Systems, Inc. · Microbiology
Aug 1988
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K882960 is an FDA 510(k) clearance for the IDS RAPID ANA SYSTEM, a Kit, Anaerobic Identification (Class I — General Controls, product code JSP), submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 12, 1988, 29 days after receiving the submission on July 14, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K882960 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1988
Decision Date August 12, 1988
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSP — Kit, Anaerobic Identification
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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