Cleared Traditional

BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802

K873218 · Lakewood Biochemical Co., Inc. · Microbiology
Sep 1987
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K873218 is an FDA 510(k) clearance for the BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802, a Culture Media, Selective Broth (Class I — General Controls, product code JSD), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on September 23, 1987, 40 days after receiving the submission on August 14, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K873218 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1987
Decision Date September 23, 1987
Days to Decision 40 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSD — Culture Media, Selective Broth
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360

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