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FDA 510(k)

TINA-QUANT APOLIPOPROTEIN B VER.2

K-Number: K013207 · 2001-11-13

ApplicantRoche Diagnostics Corp.
Decision Date2001-11-13
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT APOLIPOPROTEIN B 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 2001-11-13 under 510(k) number K013207. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT APOLIPOPROTEIN B VER.2?

TINA-QUANT APOLIPOPROTEIN B VER.2 is a medical device that received FDA 510(k) clearance on 2001-11-13. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K013207.

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

TINA-QUANT APOLIPOPROTEIN B VER.2 received FDA 510(k) clearance on 2001-11-13, under 510(k) number K013207.

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

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

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Other records listing Roche Diagnostics Corp. as applicant

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Related Devices (Code: DFC)

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.

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics OperationsK211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.K123046ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATORSiemens Healthcare Diagnostics, Inc.K122722COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160Roche Diagnostics

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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