Cleared Traditional

GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS

K874878 · Gen-Probe, Inc. · Microbiology
Dec 1987
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K874878 is an FDA 510(k) clearance for the GEN-PROBE(R) PACE(TM) SYSTEM 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 December 29, 1987, 29 days after receiving the submission on November 30, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K874878 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1987
Decision Date December 29, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

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