FDA 510(k)

CardioChek Plus Test System; CardioChek Plus Home Test System

K-Nummer: K193406 · 2022-02-26

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

Entscheidungsdatum2022-02-26

ProduktcodeNBW

BeratungsausschussCH

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

Zugehörige klinische Studien

Zugehörige Einträge werden automatisch anhand von Namen, Produktcodes oder anderen Metadaten abgeglichen. Eine Übereinstimmung begründet kein verifiziertes klinisches, wissenschaftliches, unternehmerisches oder regulatorisches Verhältnis; prüfen Sie die verlinkten offiziellen Quellen.

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

Weitere Einträge mit Polymer Technology Systems, Inc. D/B/A Pts Diagnostics als Antragsteller

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

Verwandte Geräte (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.

Offizielle Quelle

In der FDA-Datenbank anzeigen →

Daten aus der FDA Open API. Für die aktuellsten und verbindlichen Informationen konsultieren Sie bitte stets den offiziellen Datensatz.