Cleared Traditional

HAM'S MIXTURE F-12 MEDIUM

K850227 · Hazleton Research Products, Inc. · Pathology
Mar 1985
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K850227 is an FDA 510(k) clearance for the HAM'S MIXTURE F-12 MEDIUM, a Media And Components, Synthetic Cell And Tissue Culture (Class I — General Controls, product code KIT), submitted by Hazleton Research Products, Inc. (Denver, US). The FDA issued a Cleared decision on March 11, 1985, 48 days after receiving the submission on January 22, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K850227 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1985
Decision Date March 11, 1985
Days to Decision 48 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KIT — Media And Components, Synthetic Cell And Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2220