Cleared Traditional

TODD HEWITT W/CNA (LIM BROTH)

K871447 · Remel Co. · Microbiology
May 1987
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K871447 is an FDA 510(k) clearance for the TODD HEWITT W/CNA (LIM BROTH), a Culture Media, Selective Broth (Class I — General Controls, product code JSD), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on May 13, 1987, 30 days after receiving the submission on April 13, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K871447 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1987
Decision Date May 13, 1987
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSD — Culture Media, Selective Broth
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360

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