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FDA 510(k)

TINA-QUANT APOLIPOPROTEIN A-1 VER.2

K-Number: K013278 · 2001-11-15

ApplicantRoche Diagnostics Corp.
Decision Date2001-11-15
Product CodeDEL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT APOLIPOPROTEIN A-1 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 2001-11-15 under 510(k) number K013278. The device is classified under product code DEL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT APOLIPOPROTEIN A-1 VER.2?

TINA-QUANT APOLIPOPROTEIN A-1 VER.2 is a medical device that received FDA 510(k) clearance on 2001-11-15. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K013278.

When did TINA-QUANT APOLIPOPROTEIN A-1 VER.2 receive FDA 510(k) clearance?

TINA-QUANT APOLIPOPROTEIN A-1 VER.2 received FDA 510(k) clearance on 2001-11-15, under 510(k) number K013278.

Who is the listed applicant for TINA-QUANT APOLIPOPROTEIN A-1 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 A-1 VER.2?

The FDA product code for TINA-QUANT APOLIPOPROTEIN A-1 VER.2 is DEL.

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Related Devices (Code: DEL)

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.

K901675APOLIPOPROTEIN A-I (APO A-I)Sigma Chemical Co.K900124APOLIPOPROTEIN B (APO B)Sigma Chemical Co.K895160ORTHO *APO A-1 ELISA TEST SYSTEMMedical Marketing Consultants, Inc.K893885BACTON TM, BASIC TM, APO A-I REAGENTCatachem, 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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