Cleared Traditional

GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT

K962217 · Gen-Probe, Inc. · Microbiology
Nov 1996
Decision
170d
Days
Class 1
Risk

About This 510(k) Submission

K962217 is an FDA 510(k) clearance for the GEN-PROBE AMPLIFIED CHLAMYDIA TRACHOMATIS ASSAY KIT, a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I — General Controls, product code MKZ), submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on November 27, 1996, 170 days after receiving the submission on June 10, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K962217 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 1996
Decision Date November 27, 1996
Days to Decision 170 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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