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FDA 510(k)

PTS PANELS LDL CHOLESTEROL TEST STRIPS

K-Number: K040693 · 2004-07-06

ApplicantPolymer Technology Systems, Inc.
Decision Date2004-07-06
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PTS PANELS LDL 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 2004-07-06 under 510(k) number K040693. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTS PANELS LDL CHOLESTEROL TEST STRIPS?

PTS PANELS LDL CHOLESTEROL TEST STRIPS is a medical device that received FDA 510(k) clearance on 2004-07-06. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K040693.

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

PTS PANELS LDL CHOLESTEROL TEST STRIPS received FDA 510(k) clearance on 2004-07-06, under 510(k) number K040693.

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

The FDA product code for PTS PANELS LDL CHOLESTEROL TEST STRIPS is MRR.

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Other records listing Polymer Technology Systems, Inc. as applicant

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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: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AGK161691Direct LDL Cholesterol (LDL)Randox Laboratories LimitedK091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022Alfa Wassermann, Inc.K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcience

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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