Cleared Traditional

DENTOCULT-SM CULTURE-PADDLE

K872301 · Orion Corp. · Microbiology
Sep 1987
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K872301 is an FDA 510(k) clearance for the DENTOCULT-SM CULTURE-PADDLE, a Culture Media, Selective And Differential (Class I — General Controls, product code JSI), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on September 11, 1987, 88 days after receiving the submission on June 15, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K872301 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 1987
Decision Date September 11, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSI — Culture Media, Selective And Differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360