Cleared Traditional

RPMI-1640 HYBRI-MAX, PROD. NO. R5382

K884572 · Sigma Chemical Co. · Pathology
Nov 1988
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K884572 is an FDA 510(k) clearance for the RPMI-1640 HYBRI-MAX, PROD. NO. R5382, a Media And Components, Synthetic Cell And Tissue Culture (Class I — General Controls, product code KIT), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on November 22, 1988, 21 days after receiving the submission on November 1, 1988. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K884572 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1988
Decision Date November 22, 1988
Days to Decision 21 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

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