Cleared Traditional

CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597

K880945 · Lakewood Biochemical Co., Inc. · Microbiology
Mar 1988
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K880945 is an FDA 510(k) clearance for the CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597, 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 March 30, 1988, 23 days after receiving the submission on March 7, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K880945 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1988
Decision Date March 30, 1988
Days to Decision 23 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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