Cleared Traditional

TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050

K874345 · Lakewood Biochemical Co., Inc. · Microbiology
Nov 1987
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K874345 is an FDA 510(k) clearance for the TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050, a Culture Media, Selective And Non-differential (Class I — General Controls, product code JSJ), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on November 6, 1987, 17 days after receiving the submission on October 20, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K874345 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1987
Decision Date November 06, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSJ — Culture Media, Selective And Non-differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360

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