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FDA 510(k)

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

K-Number: K121610 · 2013-08-08

ApplicantRoche Diagnostics Operations
Decision Date2013-08-08
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations. It received FDA 510(k) clearance on 2013-08-08 under 510(k) number K121610. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY?

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY is a medical device that received FDA 510(k) clearance on 2013-08-08. The listed applicant is Roche Diagnostics Operations. The 510(k) number is K121610.

When did COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY receive FDA 510(k) clearance?

COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY received FDA 510(k) clearance on 2013-08-08, under 510(k) number K121610.

Who is the listed applicant for COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY?

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

What is the FDA product code for COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY?

The FDA product code for COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY is PDJ.

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Related Devices (Code: PDJ)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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