Cleared Traditional

K874537: KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR

K874537 · Lakewood Biochemical Co., Inc. · Microbiology
Nov 1987
Decision
17d
Days
Class 1
Risk

K874537 is an FDA 510(k) clearance for the KLIGLER IRON AGAR AND TRIPLE SUGAR IRON AGAR, a Culture Media, Multiple Biochemical Test (Class I — General Controls, product code JSE), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on November 20, 1987, 17 days after receiving the submission on November 3, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K874537 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1987
Decision Date November 20, 1987
Days to Decision 17 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