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FDA 510(k)

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control

K-Number: K153730 · 2016-06-15

ApplicantAbbott Laboratories
Decision Date2016-06-15
Product CodeLIP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2016-06-15 under approval number K153730. The device is classified under product code LIP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is a medical device that received FDA 510(k) clearance on 2016-06-15. It is manufactured by Abbott Laboratories. The 510(k) number is K153730.

When was ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control approved by the FDA?

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control received FDA 510(k) clearance on 2016-06-15, under approval number K153730.

What company makes ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is manufactured by Abbott Laboratories.

What is the FDA product code for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

The FDA product code for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control is LIP.

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Related Devices (Code: LIP)

K160910Elecsys SyphilisRoche Diagnostics K153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc. K170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad Laboratories K211302Elecsys SyphilisRoche Diagnostics K241427Access SyphilisBeckman Coulter, Inc. K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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