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FDA 510(k)

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

K-Number: K160571 · 2016-12-19

ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2016-12-19
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is a medical device manufactured by Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-12-19 under approval number K160571. 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 c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay?

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is a medical device that received FDA 510(k) clearance on 2016-12-19. It is manufactured by Roche Diagnostics Operations (Rdo). The 510(k) number is K160571.

When was cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay approved by the FDA?

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay received FDA 510(k) clearance on 2016-12-19, under approval number K160571.

What company makes cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay?

cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is manufactured by Roche Diagnostics Operations (Rdo).

What is the FDA product code for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay?

The FDA product code for cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay is PDJ.

Related PubMed Literature

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K161687D-10 Hemoglobin A1c ProgramBio-Rad Laboratories, Inc. K171771ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) AssaySiemens Healthcare Diagnostics, Inc. K171537CAPI 3 Hb A1cSebia K162822ADAMS A1c HA-8180V, CALIBRATOR 80Arkray Factory, Inc. K182988Afinion HbA1c Dx on Afinion 2Alere Technologies AS K173909Dimension Hemoglobin A1c AssaySiemens Healthcare Diagnostics, 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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