Cleared Traditional

HEKTOEN ENTERIC AGAR

K864242 · Mds Laboratories, Inc. · Microbiology
Mar 1987
Decision
154d
Days
Class 1
Risk

About This 510(k) Submission

K864242 is an FDA 510(k) clearance for the HEKTOEN ENTERIC AGAR, a Culture Media, Selective And Differential (Class I — General Controls, product code JSI), submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987, 154 days after receiving the submission on October 28, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K864242 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1986
Decision Date March 31, 1987
Days to Decision 154 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