Cleared Traditional

KLIGLER IRON AGAR

K834001 · Micro Media Laboratories · Microbiology
Dec 1983
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K834001 is an FDA 510(k) clearance for the KLIGLER IRON AGAR, a Culture Media, Multiple Biochemical Test (Class I — General Controls, product code JSE), submitted by Micro Media Laboratories (Mchenry, US). The FDA issued a Cleared decision on December 22, 1983, 31 days after receiving the submission on November 21, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K834001 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1983
Decision Date December 22, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSE — Culture Media, Multiple Biochemical Test
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2320