Cleared Traditional

RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER

K861875 · Hazleton Research Products, Inc. · Pathology
May 1986
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K861875 is an FDA 510(k) clearance for the RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER, 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 May 29, 1986, 14 days after receiving the submission on May 15, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K861875 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1986
Decision Date May 29, 1986
Days to Decision 14 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