Cleared Traditional

STAPH-A-LEX(TM) SYSTEM

K926173 · Trinity Laboratories, Inc. · Microbiology
Aug 1993
Decision
245d
Days
Class 1
Risk

About This 510(k) Submission

K926173 is an FDA 510(k) clearance for the STAPH-A-LEX(TM) SYSTEM, a Kit, Screening, Staphylococcus Aureus (Class I — General Controls, product code JWX), submitted by Trinity Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on August 10, 1993, 245 days after receiving the submission on December 8, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K926173 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1992
Decision Date August 10, 1993
Days to Decision 245 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JWX — Kit, Screening, Staphylococcus Aureus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660