Cleared Traditional

ORICULT-N CULTURE-PADDLE

K872058 · Orion Corp. · Microbiology
Jun 1987
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K872058 is an FDA 510(k) clearance for the ORICULT-N 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 June 10, 1987, 13 days after receiving the submission on May 28, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K872058 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1987
Decision Date June 10, 1987
Days to Decision 13 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