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)

IMMUNOCAP THYRLOBULIN IMMUNOCAP

K-Number: K072661 · 2007-11-20

ApplicantPhadia US, Inc.
Decision Date2007-11-20
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOCAP THYRLOBULIN IMMUNOCAP is the device name listed in this FDA 510(k) record. The listed applicant is Phadia US, Inc.. It received FDA 510(k) clearance on 2007-11-20 under 510(k) number K072661. The device is classified under product code JNL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOCAP THYRLOBULIN IMMUNOCAP?

IMMUNOCAP THYRLOBULIN IMMUNOCAP is a medical device that received FDA 510(k) clearance on 2007-11-20. The listed applicant is Phadia US, Inc.. The 510(k) number is K072661.

When did IMMUNOCAP THYRLOBULIN IMMUNOCAP receive FDA 510(k) clearance?

IMMUNOCAP THYRLOBULIN IMMUNOCAP received FDA 510(k) clearance on 2007-11-20, under 510(k) number K072661.

Who is the listed applicant for IMMUNOCAP THYRLOBULIN IMMUNOCAP?

The FDA 510(k) record lists Phadia US, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOCAP THYRLOBULIN IMMUNOCAP?

The FDA product code for IMMUNOCAP THYRLOBULIN IMMUNOCAP is JNL.

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 Phadia US, 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.

K131821ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAYK122197AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIESK113841IMMUNOCAP ALLERGEN COMPONENTS BUNDLEK112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYK111919IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTSK102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

View all 18 devices →

Related Devices (Code: JNL)

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.

K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)Siemens Healthcare Diagnostics, Inc.K240996Access Thyroglobulin Antibody IIBeckman Coulter, Inc.K112933ACCESS THYROGLOBULIN ANITBODYBeckman Coulter, Inc.K062516ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)Beckman Coulter, Inc.K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAMonobindK962341HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)Hycor Biomedical, 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.

↑