Cleared Traditional

SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326

K882182 · Lakewood Biochemical Co., Inc. · Microbiology
Jun 1988
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K882182 is an FDA 510(k) clearance for the SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326, a Culture Media, Selective And Differential (Class I — General Controls, product code JSI), submitted by Lakewood Biochemical Co., Inc. (Dallas, US). The FDA issued a Cleared decision on June 6, 1988, 13 days after receiving the submission on May 24, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K882182 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1988
Decision Date June 06, 1988
Days to Decision 13 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSI — Culture Media, Selective And Differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2360