Cleared Traditional

PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP

K852125 · Kallestad Laboratories, Inc. · Microbiology
Jul 1985
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K852125 is an FDA 510(k) clearance for the PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP, a Antisera, Fluorescent, Herpesvirus Hominis 1,2 (Class II — Special Controls, product code GQL), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on July 30, 1985, 76 days after receiving the submission on May 15, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3305.

Submission Details

510(k) Number K852125 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1985
Decision Date July 30, 1985
Days to Decision 76 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GQL — Antisera, Fluorescent, Herpesvirus Hominis 1,2
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3305

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