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FDA 510(k)

TINA-QUANT CERULOPLASMIN

K-Number: K091741 · 2010-03-18

ApplicantRoche Diagnostics
Decision Date2010-03-18
Product CodeCHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT CERULOPLASMIN is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2010-03-18 under 510(k) number K091741. The device is classified under product code CHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT CERULOPLASMIN?

TINA-QUANT CERULOPLASMIN is a medical device that received FDA 510(k) clearance on 2010-03-18. The listed applicant is Roche Diagnostics. The 510(k) number is K091741.

When did TINA-QUANT CERULOPLASMIN receive FDA 510(k) clearance?

TINA-QUANT CERULOPLASMIN received FDA 510(k) clearance on 2010-03-18, under 510(k) number K091741.

Who is the listed applicant for TINA-QUANT CERULOPLASMIN?

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

What is the FDA product code for TINA-QUANT CERULOPLASMIN?

The FDA product code for TINA-QUANT CERULOPLASMIN is CHN.

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Related Devices (Code: CHN)

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.

K063655DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGHDade Behring, Inc.K062114CERULOPLASMIN, MODEL 2055953Roche Diagnostics Corp.

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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