Cleared Traditional

SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331

K873324 · Lakewood Biochemical Co., Inc. · Microbiology
Oct 1987
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K873324 is an FDA 510(k) clearance for the SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331, 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 October 2, 1987, 45 days after receiving the submission on August 18, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K873324 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1987
Decision Date October 02, 1987
Days to Decision 45 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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