Cleared Traditional

ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03

K092704 · Abbott Molecular, Inc. · Microbiology
May 2010
Decision
267d
Days
Class 1
Risk

About This 510(k) Submission

K092704 is an FDA 510(k) clearance for the ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03, a Dna-reagents, Chlamydia (Class I — General Controls, product code LSK), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 28, 2010, 267 days after receiving the submission on September 3, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K092704 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2009
Decision Date May 28, 2010
Days to Decision 267 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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