Cleared Traditional

MICRO CULTURE MEDIA P3141, P3136, P3148, P3748

K873952 · Lakewood Biochemical Co., Inc. · Microbiology
Oct 1987
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K873952 is an FDA 510(k) clearance for the MICRO CULTURE MEDIA P3141, P3136, P3148, P3748, a Culture Media, Enriched (Class I — General Controls, product code KZI), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on October 23, 1987, 25 days after receiving the submission on September 28, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2330.

Submission Details

510(k) Number K873952 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1987
Decision Date October 23, 1987
Days to Decision 25 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KZI — Culture Media, Enriched
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2330