Cleared Traditional

SFRE 199-1 MEDIUM, CATALOG NO. 200-2191

K883451 · J R Scientific · Pathology
Aug 1988
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K883451 is an FDA 510(k) clearance for the SFRE 199-1 MEDIUM, CATALOG NO. 200-2191, 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 August 30, 1988, 15 days after receiving the submission on August 15, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K883451 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1988
Decision Date August 30, 1988
Days to Decision 15 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