Cleared Traditional

BME AUTOCLAVABLE MEDIUM

K821915 · Dutchland Laboratories, Inc. · Microbiology
Jul 1982
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K821915 is an FDA 510(k) clearance for the BME AUTOCLAVABLE MEDIUM, a Media And Components, Synthetic Cell And Tissue Culture (Class I — General Controls, product code KIT), submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1982, 29 days after receiving the submission on June 28, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K821915 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 1982
Decision Date July 27, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
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