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)

CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY

K-Number: K934562 · 1993-12-10

ApplicantCiba Corning Diagnostics Corp.
Decision Date1993-12-10
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Ciba Corning Diagnostics Corp.. It received FDA 510(k) clearance on 1993-12-10 under 510(k) number K934562. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY?

CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1993-12-10. The listed applicant is Ciba Corning Diagnostics Corp.. The 510(k) number is K934562.

When did CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY receive FDA 510(k) clearance?

CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY received FDA 510(k) clearance on 1993-12-10, under 510(k) number K934562.

Who is the listed applicant for CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY?

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

What is the FDA product code for CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY?

The FDA product code for CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY is CDZ.

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 Ciba Corning Diagnostics Corp. 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.

K962559ACS CORTISOL IMMUNOASSAYK963251CIBA CORNING ACS;180 DPD ASSAYK961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4K961657CIBA CORNING 400 SYSTEMK962021CIBA CORNING 348 SYSTEMK962126ACS CKMB II IMMUNOASSAY

View all 125 devices →

Related Devices (Code: CDZ)

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.

K252728IDS-iSYS Total TestosteroneImmunodiagnostic Systems LimitedK240865IDS-iSYS Free TestosteroneImmunodiagnostic Systems LimitedK233480Access SHBGBeckman Coulter, Inc.K223405Access TestosteroneBeckman Coulter, Inc.K211685Elecsys Testosterone IIRoche DiagnosticsK201908LIAISON Testosterone xtDiaSorin, 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.

↑