Cleared Traditional

DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM

K861996 · Hazleton Research Products, Inc. · Pathology
Jun 1986
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K861996 is an FDA 510(k) clearance for the DULBECCO'S MEM WITH 4.5 G/L GLUCOSE 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 June 9, 1986, 17 days after receiving the submission on May 23, 1986. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K861996 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 1986
Decision Date June 09, 1986
Days to Decision 17 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