Cleared Traditional

GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR

K940979 · Gen-Probe, Inc. · Microbiology
Oct 1994
Decision
244d
Days
Class 2
Risk

About This 510(k) Submission

K940979 is an FDA 510(k) clearance for the GEN-PROBE PACE 2C SYST CHLAMYDIA TRAC/NEISSER GONORR, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on October 31, 1994, 244 days after receiving the submission on March 1, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K940979 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1994
Decision Date October 31, 1994
Days to Decision 244 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSL — Dna-reagents, Neisseria
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3390

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