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FDA 510(k)

CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System

K-Number: K151545 · 2016-12-22

ApplicantPolymer Technology Systems, Inc.
Decision Date2016-12-22
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System is the device name listed in this FDA 510(k) record. The listed applicant is Polymer Technology Systems, Inc.. It received FDA 510(k) clearance on 2016-12-22 under 510(k) number K151545. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System?

CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K151545.

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

CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System received FDA 510(k) clearance on 2016-12-22, under 510(k) number K151545.

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

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

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

The FDA product code for CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System is CHH.

Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, 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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