Cleared Traditional

RPMI-1640 MEDIUM, CATALOG NO. 210-3525

K883630 · J R Scientific · Pathology
Sep 1988
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K883630 is an FDA 510(k) clearance for the RPMI-1640 MEDIUM, CATALOG NO. 210-3525, 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 7, 1988, 16 days after receiving the submission on August 22, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K883630 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1988
Decision Date September 07, 1988
Days to Decision 16 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