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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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2016-06-15 under 510(k) 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. The listed applicant is Abbott Laboratories. The 510(k) number is K153730.

When did ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control receive FDA 510(k) clearance?

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

Who is the listed applicant for ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241427Access SyphilisBeckman Coulter, Inc.K241534VITROS Immunodiagnostic Products Syphilis Reagent PackOrtho Clinical DiagnosticsK211302Elecsys SyphilisRoche DiagnosticsK170413BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control SetBio-Rad LaboratoriesK160910Elecsys SyphilisRoche DiagnosticsK153145Lumipulse G TP-N Immunoreaction Cartridge SetFujirebio Diagnostics,Inc.

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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