Cleared Traditional

PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS

K920378 · Gen-Probe, Inc. · Microbiology
Apr 1992
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K920378 is an FDA 510(k) clearance for the PACE 2 SYSTEM FOR CHLAMYDIA TRACHOMATIS, a Dna-reagents, Chlamydia (Class I — General Controls, product code LSK), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on April 29, 1992, 91 days after receiving the submission on January 29, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K920378 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1992
Decision Date April 29, 1992
Days to Decision 91 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSK — Dna-reagents, Chlamydia
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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