Cleared Traditional

DIAMOND'S MEDIUM MODIFIED

K881995 · Remel Co. · Microbiology
Jun 1988
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K881995 is an FDA 510(k) clearance for the DIAMOND'S MEDIUM MODIFIED, a Culture Media, Enriched (Class I — General Controls, product code KZI), submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 2, 1988, 21 days after receiving the submission on May 12, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2330.

Submission Details

510(k) Number K881995 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1988
Decision Date June 02, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code KZI — Culture Media, Enriched
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2330