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FDA 510(k)

PTS PANELS LIPID PANEL TEST STRIPS

K-Number: K022898 · 2002-09-24

ApplicantPolymer Technology Systems, Inc.
Decision Date2002-09-24
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PTS PANELS LIPID PANEL TEST STRIPS 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 2002-09-24 under 510(k) number K022898. 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 PTS PANELS LIPID PANEL TEST STRIPS?

PTS PANELS LIPID PANEL TEST STRIPS is a medical device that received FDA 510(k) clearance on 2002-09-24. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K022898.

When did PTS PANELS LIPID PANEL TEST STRIPS receive FDA 510(k) clearance?

PTS PANELS LIPID PANEL TEST STRIPS received FDA 510(k) clearance on 2002-09-24, under 510(k) number K022898.

Who is the listed applicant for PTS PANELS LIPID PANEL TEST STRIPS?

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 PTS PANELS LIPID PANEL TEST STRIPS?

The FDA product code for PTS PANELS LIPID PANEL TEST STRIPS is CHH.

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Other records listing Polymer Technology Systems, Inc. as applicant

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.

K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test SystemK071593PTS PANELS CHOL+HDL PANEL TEST STRIPSK071507PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPSK070017PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPSK060617PTS PANELS HDL CHOLESTEROL TEST STRIPSK041750PTS PANELS CHOL+GLU TEST PANEL

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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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