Cleared Traditional

RAPID NF SYSTEM

K900517 · Innovative Diagnostic Systems, Inc. · Microbiology

Mar 1990

Decision

39d

Days

Class 1

Risk

About This 510(k) Submission

K900517 is an FDA 510(k) clearance for the RAPID NF SYSTEM, a Kit, Identification, Glucose Nonfermenter (Class I — General Controls, product code JSW), submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on March 13, 1990, 39 days after receiving the submission on February 2, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K900517 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 02, 1990
Decision Date	March 13, 1990
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—