Cleared Traditional

SELECTIVE STREPTOCOCCUS AGAR

K834005 · Micro Media Laboratories · Microbiology
Jan 1984
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K834005 is an FDA 510(k) clearance for the SELECTIVE STREPTOCOCCUS AGAR, a Culture Media, Selective And Non-differential (Class I — General Controls, product code JSJ), submitted by Micro Media Laboratories (Mchenry, US). The FDA issued a Cleared decision on January 3, 1984, 43 days after receiving the submission on November 21, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K834005 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1983
Decision Date January 03, 1984
Days to Decision 43 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSJ — Culture Media, Selective And Non-differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360

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