Cleared Traditional

K851346 - PHENYLALANINE AGAR
(FDA 510(k) Clearance)

K851346 · Micro Media Laboratories · Microbiology
Apr 1985
Decision
15d
Days
Class 1
Risk

K851346 is an FDA 510(k) clearance for the PHENYLALANINE AGAR, a Culture Media, Non-selective And Differential (Class I — General Controls, product code JSH), submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on April 19, 1985, 15 days after receiving the submission on April 4, 1985. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2320.

Submission Details

510(k) Number K851346 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1985
Decision Date April 19, 1985
Days to Decision 15 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