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FDA 510(k)

CERULOPLASMIN, MODEL 2055953

K-Number: K062114 · 2007-01-31

ApplicantRoche Diagnostics Corp.
Decision Date2007-01-31
Product CodeCHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CERULOPLASMIN, MODEL 2055953 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 2007-01-31 under 510(k) number K062114. 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 CERULOPLASMIN, MODEL 2055953?

CERULOPLASMIN, MODEL 2055953 is a medical device that received FDA 510(k) clearance on 2007-01-31. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K062114.

When did CERULOPLASMIN, MODEL 2055953 receive FDA 510(k) clearance?

CERULOPLASMIN, MODEL 2055953 received FDA 510(k) clearance on 2007-01-31, under 510(k) number K062114.

Who is the listed applicant for CERULOPLASMIN, MODEL 2055953?

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 CERULOPLASMIN, MODEL 2055953?

The FDA product code for CERULOPLASMIN, MODEL 2055953 is CHN.

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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: 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.

K091741TINA-QUANT CERULOPLASMINRoche DiagnosticsK063655DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGHDade Behring, 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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