Cleared Traditional

A.C.T. II

K965152 · Remel Co. · Microbiology
Jan 1997
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K965152 is an FDA 510(k) clearance for the A.C.T. II, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on January 22, 1997, 30 days after receiving the submission on December 23, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K965152 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1996
Decision Date January 22, 1997
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JSM — Culture Media, Non-propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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