Cleared Traditional

CORN MEAL W/POLYSORBATE 80

K880108 · Hardy Media · Microbiology
Mar 1988
Decision
84d
Days
Class 1
Risk

About This 510(k) Submission

K880108 is an FDA 510(k) clearance for the CORN MEAL W/POLYSORBATE 80, a Culture Media, Selective And Differential (Class I — General Controls, product code JSI), submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 30, 1988, 84 days after receiving the submission on January 6, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number K880108 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1988
Decision Date March 30, 1988
Days to Decision 84 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