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FDA 510(k)

BIOSCANNER PLUS; LIPID PANEL TEST STRIPS

K-Number: K013173 · 2001-10-22

ApplicantPolymer Technology Systems, Inc.
Decision Date2001-10-22
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BIOSCANNER PLUS; 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 2001-10-22 under 510(k) number K013173. 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 BIOSCANNER PLUS; LIPID PANEL TEST STRIPS?

BIOSCANNER PLUS; LIPID PANEL TEST STRIPS is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Polymer Technology Systems, Inc.. The 510(k) number is K013173.

When did BIOSCANNER PLUS; LIPID PANEL TEST STRIPS receive FDA 510(k) clearance?

BIOSCANNER PLUS; LIPID PANEL TEST STRIPS received FDA 510(k) clearance on 2001-10-22, under 510(k) number K013173.

Who is the listed applicant for BIOSCANNER PLUS; 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 BIOSCANNER PLUS; LIPID PANEL TEST STRIPS?

The FDA product code for BIOSCANNER PLUS; LIPID PANEL TEST STRIPS is CHH.

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Other records listing Polymer Technology Systems, Inc. as applicant

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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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