Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TINA-QUANT ALBUMIN GEN.2

K-Number: K113072 · 2012-05-14

ApplicantRoche Diagnostics Operations
Decision Date2012-05-14
Product CodeDCF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT ALBUMIN GEN.2 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 2012-05-14 under 510(k) number K113072. The device is classified under product code DCF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TINA-QUANT ALBUMIN GEN.2?

TINA-QUANT ALBUMIN GEN.2 is a medical device that received FDA 510(k) clearance on 2012-05-14. The listed applicant is Roche Diagnostics Operations. The 510(k) number is K113072.

When did TINA-QUANT ALBUMIN GEN.2 receive FDA 510(k) clearance?

TINA-QUANT ALBUMIN GEN.2 received FDA 510(k) clearance on 2012-05-14, under 510(k) number K113072.

Who is the listed applicant for TINA-QUANT ALBUMIN GEN.2?

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 TINA-QUANT ALBUMIN GEN.2?

The FDA product code for TINA-QUANT ALBUMIN GEN.2 is DCF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Roche Diagnostics Operations 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.

K241220Tina-quant Lipoprotein(a) Gen.2 MolarityK233454ONLINE TDM MethotrexateK163633cobas HbA1c Test, cobas b 101 systemK121610COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY

Related Devices (Code: DCF)

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.

K153560Optilite Low Level Albumin KitThe Binding Site Group , Ltd.K121045HUMAN ALBUMIN CSF KITThe Binding Site Group , Ltd.K101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATORMedica Corp.K101203TINA-QUANT ALBUMIN GEN 2Roche DiagnosticsK100853COBAS 8000 MODULAR SERIES ANALYZERRoche Diagnostics Corp.K091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORKamiya Biomedical Co.

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.

↑