Cleared Traditional

Aptima Combo 2 Assay (Panther System)

K180681 · Hologic, Inc. · Microbiology
Jun 2018
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K180681 is an FDA 510(k) clearance for the Aptima Combo 2 Assay (Panther System), a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on June 13, 2018, 90 days after receiving the submission on March 15, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K180681 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2018
Decision Date June 13, 2018
Days to Decision 90 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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