Cleared Traditional

PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY

K920302 · Gen-Probe, Inc. · Microbiology
Apr 1994
Decision
806d
Days
Class 1
Risk

About This 510(k) Submission

K920302 is an FDA 510(k) clearance for the PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY, 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 6, 1994, 806 days after receiving the submission on January 21, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K920302 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1992
Decision Date April 06, 1994
Days to Decision 806 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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