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)

C. PTH RADIOIMMUNOASSAY KIT-CPTHK

K-Number: K833768 · 1983-12-29

ApplicantSorin Biomedica, Fiat, USA, Inc.
Decision Date1983-12-29
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

C. PTH RADIOIMMUNOASSAY KIT-CPTHK 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 1983-12-29 under 510(k) number K833768. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C. PTH RADIOIMMUNOASSAY KIT-CPTHK?

C. PTH RADIOIMMUNOASSAY KIT-CPTHK is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is Sorin Biomedica, Fiat, USA, Inc.. The 510(k) number is K833768.

When did C. PTH RADIOIMMUNOASSAY KIT-CPTHK receive FDA 510(k) clearance?

C. PTH RADIOIMMUNOASSAY KIT-CPTHK received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833768.

Who is the listed applicant for C. PTH RADIOIMMUNOASSAY KIT-CPTHK?

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 C. PTH RADIOIMMUNOASSAY KIT-CPTHK?

The FDA product code for C. PTH RADIOIMMUNOASSAY KIT-CPTHK is CEW.

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 MODULEK925369BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMSK925615SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBEK924354STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITORK925541STOCKERT 1/4 BUBBLE SENSOR

View all 20 devices →

Related Devices (Code: CEW)

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.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic 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.

↑