Cleared Traditional

ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG

K140354 · Abbott Molecular, Inc. · Microbiology

May 2014

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K140354 is an FDA 510(k) clearance for the ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 9, 2014, 86 days after receiving the submission on February 12, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number	K140354 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2014
Decision Date	May 09, 2014
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF