Cleared Traditional

DENTOCULT SM-STRIP MUTANS

K890199 · Orion Corp. · Microbiology
Mar 1989
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K890199 is an FDA 510(k) clearance for the DENTOCULT SM-STRIP MUTANS, 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 March 2, 1989, 43 days after receiving the submission on January 18, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K890199 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1989
Decision Date March 02, 1989
Days to Decision 43 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

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