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)

TESTOSTERONE DIRECT RADIOIMMUNOASSAY

K-Number: K841948 · 1984-06-25

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1984-06-25
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TESTOSTERONE DIRECT RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. It received FDA 510(k) clearance on 1984-06-25 under 510(k) number K841948. 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 TESTOSTERONE DIRECT RADIOIMMUNOASSAY?

TESTOSTERONE DIRECT RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1984-06-25. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K841948.

When did TESTOSTERONE DIRECT RADIOIMMUNOASSAY receive FDA 510(k) clearance?

TESTOSTERONE DIRECT RADIOIMMUNOASSAY received FDA 510(k) clearance on 1984-06-25, under 510(k) number K841948.

Who is the listed applicant for TESTOSTERONE DIRECT RADIOIMMUNOASSAY?

The FDA 510(k) record lists Sorin Biomedica, Fiat, USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TESTOSTERONE DIRECT RADIOIMMUNOASSAY?

The FDA product code for TESTOSTERONE DIRECT RADIOIMMUNOASSAY 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 Sorin Biomedica, Fiat, USA, Inc. 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.

K931444PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORSK925661STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULEK925615SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBEK925369BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMSK924354STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITORK925541STOCKERT 1/4 BUBBLE SENSOR

View all 20 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.

↑