Cleared Traditional

FEKAL CHECK PARASITOLOGY CONTROL SLIDE

K862914 · Trend Scientific, Inc. · Microbiology
Sep 1986
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K862914 is an FDA 510(k) clearance for the FEKAL CHECK PARASITOLOGY CONTROL SLIDE, a Kit, Quality Control For Culture Media (Class I — General Controls, product code JTR), submitted by Trend Scientific, Inc. (New Brighton, US). The FDA issued a Cleared decision on September 16, 1986, 46 days after receiving the submission on August 1, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2480.

Submission Details

510(k) Number K862914 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1986
Decision Date September 16, 1986
Days to Decision 46 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTR — Kit, Quality Control For Culture Media
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2480

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