Cleared Traditional

CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800

K973457 · Shared Systems, Inc. · Microbiology
Jan 1998
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K973457 is an FDA 510(k) clearance for the CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800, a Antigens, All Types, Escherichia Coli (Class I — General Controls, product code GMZ), submitted by Shared Systems, Inc. (Martinez, US). The FDA issued a Cleared decision on January 2, 1998, 112 days after receiving the submission on September 12, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3255.

Submission Details

510(k) Number K973457 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1997
Decision Date January 02, 1998
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GMZ — Antigens, All Types, Escherichia Coli
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3255

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