Cleared Traditional

TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020

K873483 · Lakewood Biochemical Co., Inc. · Microbiology
Oct 1987
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K873483 is an FDA 510(k) clearance for the TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020, a Culture Media, Non-selective And Non-differential (Class I — General Controls, product code JSG), 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 866.2300.

Submission Details

510(k) Number K873483 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 JSG — Culture Media, Non-selective And Non-differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2300

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