Cleared Traditional

DENTOCULT CULTURE-PADDLE

K851164 · Orion Corp. · Microbiology
Oct 1985
Decision
221d
Days
Class 1
Risk

About This 510(k) Submission

K851164 is an FDA 510(k) clearance for the DENTOCULT CULTURE-PADDLE, a Counter (beta, Gamma) For Clinical Use (Class I — General Controls, product code JJJ), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on October 29, 1985, 221 days after receiving the submission on March 22, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2320.

Submission Details

510(k) Number K851164 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 1985
Decision Date October 29, 1985
Days to Decision 221 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JJJ — Counter (beta, Gamma) For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2320