ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03— 510(k) K092704

Name: FDA 510(k) clearance K092704
Creator: U.S. Food and Drug Administration
Published: 2010-05-28

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K092704 for ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03, Substantially Equivalent on 2010-05-28. Applicant: Abbott Molecular, Inc.. Device class: 1.

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code LSK
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 2009-09-03
Decision date: 2010-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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