Cleared Traditional

MODIFIED IDS RAPID NH SYSTEM

K881501 · Innovative Diagnostic Systems, Inc. · Microbiology

May 1988

Decision

37d

Days

Class 1

Risk

About This 510(k) Submission

K881501 is an FDA 510(k) clearance for the MODIFIED IDS RAPID NH SYSTEM, a Kit, Identification, Neisseria Gonorrhoeae (Class I — General Controls, product code JSX), submitted by Innovative Diagnostic Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on May 18, 1988, 37 days after receiving the submission on April 11, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K881501 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 11, 1988
Decision Date	May 18, 1988
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—