Cleared Traditional

PATHFINDER(TM) SPECIMEN COLLECTION KIT

K863682 · Kallestad Laboratories, Inc. · Microbiology
Oct 1986
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K863682 is an FDA 510(k) clearance for the PATHFINDER(TM) SPECIMEN COLLECTION KIT, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Kallestad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on October 10, 1986, 21 days after receiving the submission on September 19, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K863682 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1986
Decision Date October 10, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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