Cleared Traditional

TRYPSIN-EDTA SOLUTION

K850679 · Hazleton Research Products, Inc. · Pathology
Mar 1985
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K850679 is an FDA 510(k) clearance for the TRYPSIN-EDTA SOLUTION, 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 29, 1985, 36 days after receiving the submission on February 21, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K850679 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1985
Decision Date March 29, 1985
Days to Decision 36 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