Cleared Traditional

T9802 TSB W/6.5% NACL

K870594 · Lakewood Biochemical Co., Inc. · Microbiology
Mar 1987
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K870594 is an FDA 510(k) clearance for the T9802 TSB W/6.5% NACL, 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 March 30, 1987, 48 days after receiving the submission on February 10, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K870594 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1987
Decision Date March 30, 1987
Days to Decision 48 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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