Cleared Traditional

HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016

K873481 · Lakewood Biochemical Co., Inc. · Microbiology
Oct 1987
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K873481 is an FDA 510(k) clearance for the HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016, a Culture Media, Selective And Differential (Class I — General Controls, product code JSI), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on October 8, 1987, 42 days after receiving the submission on August 27, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K873481 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1987
Decision Date October 08, 1987
Days to Decision 42 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