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)

HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)

K-Number: K962341 · 1996-11-25

ApplicantHycor Biomedical, Inc.
Decision Date1996-11-25
Product CodeJNL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical, Inc.. It received FDA 510(k) clearance on 1996-11-25 under 510(k) number K962341. 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 HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)?

HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) is a medical device that received FDA 510(k) clearance on 1996-11-25. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K962341.

When did HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) receive FDA 510(k) clearance?

HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) received FDA 510(k) clearance on 1996-11-25, under 510(k) number K962341.

Who is the listed applicant for HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)?

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

What is the FDA product code for HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)?

The FDA product code for HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) 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 Hycor Biomedical, 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.

K081217HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEMK080322HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200K022944AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISAK022945AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISAK965094HYCOR ALLERGEN DISCK962722HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY

View all 51 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.K072661IMMUNOCAP THYRLOBULIN IMMUNOCAPPhadia US, Inc.K062516ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)Beckman Coulter, Inc.K971834ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISAMonobind

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.

↑