Cleared Traditional

10B ARGININE BROTH

K961046 · Remel, L.P. · Microbiology
Sep 1996
Decision
187d
Days
Class 1
Risk

About This 510(k) Submission

K961046 is an FDA 510(k) clearance for the 10B ARGININE BROTH, a Culture Media, Non-propagating Transport (Class I — General Controls, product code JSM), submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on September 18, 1996, 187 days after receiving the submission on March 15, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K961046 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 1996
Decision Date September 18, 1996
Days to Decision 187 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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