Cleared Traditional

STREPTOMYCIN DISK (300MCG)

K961819 · Remel, L.P. · Microbiology
Jul 1996
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K961819 is an FDA 510(k) clearance for the STREPTOMYCIN DISK (300MCG), a Susceptibility Test Discs, Antimicrobial (Class II — Special Controls, product code JTN), submitted by Remel, L.P. (Lenexa, US). The FDA issued a Cleared decision on July 10, 1996, 61 days after receiving the submission on May 10, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1620.

Submission Details

510(k) Number K961819 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 1996
Decision Date July 10, 1996
Days to Decision 61 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JTN — Susceptibility Test Discs, Antimicrobial
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1620

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