ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control— 510(k) K153730

Name: FDA 510(k) clearance K153730
Creator: U.S. Food and Drug Administration
Published: 2016-06-15

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K153730 for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control, Substantially Equivalent on 2016-06-15. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LIP
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2015-12-28
Decision date: 2016-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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