Cleared Traditional

PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM

K863681 · Kallestad Laboratories, Inc. · Microbiology
Dec 1986
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K863681 is an FDA 510(k) clearance for the PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM, a Antiserum, Fluorescent, Chlamydia Trachomatis (Class I — General Controls, product code LJP), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on December 3, 1986, 75 days after receiving the submission on September 19, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K863681 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1986
Decision Date December 03, 1986
Days to Decision 75 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LJP — Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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