Cleared Traditional

ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105

K883363 · J R Scientific · Pathology
Aug 1988
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K883363 is an FDA 510(k) clearance for the ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105, 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 29, 1988, 20 days after receiving the submission on August 9, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K883363 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 1988
Decision Date August 29, 1988
Days to Decision 20 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