Cleared Traditional

PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323

K873975 · Lakewood Biochemical Co., Inc. · Microbiology
Oct 1987
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K873975 is an FDA 510(k) clearance for the PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323, 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 October 23, 1987, 24 days after receiving the submission on September 29, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K873975 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1987
Decision Date October 23, 1987
Days to Decision 24 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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