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FDA 510(k)

PTS PANELS HDL CHOLESTEROL TEST STRIPS

K-Number: K060617 · 2006-04-05

ApplicantPolymer Technology Systems, Inc.
Decision Date2006-04-05
Product CodeNAQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PTS PANELS HDL CHOLESTEROL 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 2006-04-05 under 510(k) number K060617. The device is classified under product code NAQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTS PANELS HDL CHOLESTEROL TEST STRIPS?

PTS PANELS HDL CHOLESTEROL TEST STRIPS is a medical device that received FDA 510(k) clearance on 2006-04-05. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K060617.

When did PTS PANELS HDL CHOLESTEROL TEST STRIPS receive FDA 510(k) clearance?

PTS PANELS HDL CHOLESTEROL TEST STRIPS received FDA 510(k) clearance on 2006-04-05, under 510(k) number K060617.

Who is the listed applicant for PTS PANELS HDL CHOLESTEROL 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 HDL CHOLESTEROL TEST STRIPS?

The FDA product code for PTS PANELS HDL CHOLESTEROL TEST STRIPS is NAQ.

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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 STRIPSK041750PTS PANELS CHOL+GLU TEST PANELK040693PTS PANELS LDL CHOLESTEROL TEST STRIPS

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Related Devices (Code: NAQ)

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.

K993377MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)Polymer Technology Systems, 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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