Cleared Traditional

REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST

K942093 · Medical Diagnostic Technologies, Inc. · Microbiology
Nov 1994
Decision
210d
Days
Class 1
Risk

About This 510(k) Submission

K942093 is an FDA 510(k) clearance for the REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Medical Diagnostic Technologies, Inc. (Augusta, US). The FDA issued a Cleared decision on November 28, 1994, 210 days after receiving the submission on May 2, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K942093 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1994
Decision Date November 28, 1994
Days to Decision 210 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GTZ — Antisera, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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