Cleared Traditional

MEDIUM 199 W/EBSS (CATALOG NO. 200-2037)

K883951 · J R Scientific · Pathology
Sep 1988
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K883951 is an FDA 510(k) clearance for the MEDIUM 199 W/EBSS (CATALOG NO. 200-2037), a Media And Components, Synthetic Cell And Tissue Culture (Class I — General Controls, product code KIT), submitted by J R Scientific (Woodland, US). The FDA issued a Cleared decision on September 30, 1988, 11 days after receiving the submission on September 19, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K883951 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1988
Decision Date September 30, 1988
Days to Decision 11 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