FDA 510(k)

PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS

K-Number: K071507 · 2007-09-10

ApplicantPolymer Technology Systems, Inc.

Decision Date2007-09-10

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

PTS PANELS CHOL+HDL+GLU 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 2007-09-10 under 510(k) number K071507. 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.

Frequently Asked Questions

What is the PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS?

PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS is a medical device that received FDA 510(k) clearance on 2007-09-10. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K071507.

When did PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS receive FDA 510(k) clearance?

PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS received FDA 510(k) clearance on 2007-09-10, under 510(k) number K071507.

Who is the listed applicant for PTS PANELS CHOL+HDL+GLU 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 CHOL+HDL+GLU PANEL TEST STRIPS?

The FDA product code for PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS is NBW. This falls under the OB/GYN category.

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Other records listing Polymer Technology Systems, Inc. as applicant

K151545CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System K071593PTS PANELS CHOL+HDL PANEL TEST STRIPS K070017PTS PANELS METABOLIC CHEMISTRY PANEL TEST STRIPS K060617PTS PANELS HDL CHOLESTEROL TEST STRIPS K041750PTS PANELS CHOL+GLU TEST PANEL K040693PTS PANELS LDL CHOLESTEROL TEST STRIPS

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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.