Cleared Traditional

MOELLERS DECARBOXYLASE, BASE

K880121 · Hardy Media · Microbiology
Mar 1988
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K880121 is an FDA 510(k) clearance for the MOELLERS DECARBOXYLASE, BASE, a Culture Media, Non-selective And Differential (Class I — General Controls, product code JSH), submitted by Hardy Media (Santa Barbara, US). The FDA issued a Cleared decision on March 31, 1988, 85 days after receiving the submission on January 6, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K880121 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1988
Decision Date March 31, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JSH — Culture Media, Non-selective And Differential
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2320