FDA 510(k)

CardioChek Plus Test System; CardioChek Plus Home Test System

Numéro K : K193406 · 2022-02-26

DemandeurPolymer Technology Systems, Inc. D/B/A Pts Diagnostics

Date de décision2022-02-26

Code produitNBW

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

CardioChek Plus Test System; CardioChek Plus Home Test System is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. It received FDA 510(k) clearance on 2022-02-26 under 510(k) number K193406. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the CardioChek Plus Test System; CardioChek Plus Home Test System?

CardioChek Plus Test System; CardioChek Plus Home Test System is a medical device that received FDA 510(k) clearance on 2022-02-26. The listed applicant is Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. The 510(k) number is K193406.

When did CardioChek Plus Test System; CardioChek Plus Home Test System receive FDA 510(k) clearance?

CardioChek Plus Test System; CardioChek Plus Home Test System received FDA 510(k) clearance on 2022-02-26, under 510(k) number K193406.

Who is the listed applicant for CardioChek Plus Test System; CardioChek Plus Home Test System?

The FDA 510(k) record lists Polymer Technology Systems, Inc. D/B/A Pts Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CardioChek Plus Test System; CardioChek Plus Home Test System?

The FDA product code for CardioChek Plus Test System; CardioChek Plus Home Test System is NBW. This falls under the OB/GYN category.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Polymer Technology Systems, Inc. D/B/A Pts Diagnostics en tant que demandeur

K182781PTS Professional Chemistry Kit K162282CardioChek Plus Test System, CardioChek Home Test System

Dispositifs connexes (Code : NBW)

K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System; CONTOUR® NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.