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FDA 510(k)

TINA-QUANT APOLIPOPROTEIN VER.2

K-Number: K013249 · 2001-11-16

ApplicantRoche Diagnostics Corp.
Decision Date2001-11-16
Product CodeDER
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT APOLIPOPROTEIN VER.2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2001-11-16 under 510(k) number K013249. The device is classified under product code DER. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT APOLIPOPROTEIN VER.2?

TINA-QUANT APOLIPOPROTEIN VER.2 is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K013249.

When did TINA-QUANT APOLIPOPROTEIN VER.2 receive FDA 510(k) clearance?

TINA-QUANT APOLIPOPROTEIN VER.2 received FDA 510(k) clearance on 2001-11-16, under 510(k) number K013249.

Who is the listed applicant for TINA-QUANT APOLIPOPROTEIN VER.2?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TINA-QUANT APOLIPOPROTEIN VER.2?

The FDA product code for TINA-QUANT APOLIPOPROTEIN VER.2 is DER.

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Other records listing Roche Diagnostics Corp. 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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: DER)

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.

K000921BAYER ADVIA IMS SYSTEM; 200 + 3Bayer Corp.K993354K-ASSAY APO BKamiya Biomedical Co.K993345K-ASSAY APO AIKamiya Biomedical Co.K990594INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1Roche Diagnostics Corp.K983289APOLIPOPROTEIN A1Abbott LaboratoriesK964292N-ASSAY TIA APO A1 TEST KITCrestat Diagnostics, 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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