Cleared Traditional

QUAD FERM +

K853544 · Analytical Products, Inc. · Microbiology
Sep 1985
Decision
10d
Days
Class 1
Risk

About This 510(k) Submission

K853544 is an FDA 510(k) clearance for the QUAD FERM +, a Kit, Identification, Neisseria Gonorrhoeae (Class I — General Controls, product code JSX), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on September 5, 1985, 10 days after receiving the submission on August 26, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K853544 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1985
Decision Date September 05, 1985
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSX — Kit, Identification, Neisseria Gonorrhoeae
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660