Cleared Traditional

TERGITOL 7 AGAR

K853691 · Micro Media Laboratories · Microbiology
Sep 1985
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K853691 is an FDA 510(k) clearance for the TERGITOL 7 AGAR, a Culture Media, Selective And Differential (Class I — General Controls, product code JSI), submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on September 17, 1985, 13 days after receiving the submission on September 4, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K853691 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1985
Decision Date September 17, 1985
Days to Decision 13 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSI — Culture Media, Selective And Differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360