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 Cystatin C Gen.2

K-Number: K161817 · 2016-07-27

ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2016-07-27
Product CodeNDY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tina-quant Cystatin C Gen.2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2016-07-27 under 510(k) number K161817. The device is classified under product code NDY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tina-quant Cystatin C Gen.2?

Tina-quant Cystatin C Gen.2 is a medical device that received FDA 510(k) clearance on 2016-07-27. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K161817.

When did Tina-quant Cystatin C Gen.2 receive FDA 510(k) clearance?

Tina-quant Cystatin C Gen.2 received FDA 510(k) clearance on 2016-07-27, under 510(k) number K161817.

Who is the listed applicant for Tina-quant Cystatin C Gen.2?

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

What is the FDA product code for Tina-quant Cystatin C Gen.2?

The FDA product code for Tina-quant Cystatin C Gen.2 is NDY.

Other records listing Roche Diagnostics Operations (Rdo) 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.

K193053Tina-quant Hemoglobin A1cDx Gen.3K192072Tina-quant C-Reactive Protein IVK183517Ammonia IIK182095Tina-quant Transferrin ver.2 (urine application)K171080ALP IFCC Gen.2K160571cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

View all 10 devices →

Related Devices (Code: NDY)

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.

K242585Cystatin CSENTINEL CH. SpAK181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc.K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH

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.

↑