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)

Elecsys CYFRA 21-1 CalCheck 5

K-Number: K162173 · 2017-01-12

ApplicantRoche Diagnostics
Decision Date2017-01-12
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys CYFRA 21-1 CalCheck 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K162173. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys CYFRA 21-1 CalCheck 5?

Elecsys CYFRA 21-1 CalCheck 5 is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Roche Diagnostics. The 510(k) number is K162173.

When did Elecsys CYFRA 21-1 CalCheck 5 receive FDA 510(k) clearance?

Elecsys CYFRA 21-1 CalCheck 5 received FDA 510(k) clearance on 2017-01-12, under 510(k) number K162173.

Who is the listed applicant for Elecsys CYFRA 21-1 CalCheck 5?

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

What is the FDA product code for Elecsys CYFRA 21-1 CalCheck 5?

The FDA product code for Elecsys CYFRA 21-1 CalCheck 5 is JJX.

Other records listing Roche Diagnostics 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.

K252323cobas pulse blood glucose monitoring systemPMA P990056Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P000027PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERSK252431Elecsys CalcitoninK252280Elecsys Anti-SARS-CoV-2 SK260049Elecsys Anti-HBc IgM

View all 84 devices →

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersImmunodiagnostic Systems , Ltd.

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.

↑