FDA 510(k)

ARCHITECT Syphilis TP Réactif, ARCHITECT Syphilis TP Calibrateur, ARCHITECT Syphilis TP Contrôle

Numéro K : K153730 · 2016-06-15

Date de décision2016-06-15

Code produitLIP

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : LIP)

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Source officielle

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