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)

A-GENT QUANTICHROM T4 11A

K-Number: K790848 · 1979-08-10

ApplicantAbbott Laboratories
Decision Date1979-08-10
Product CodeKLI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A-GENT QUANTICHROM T4 11A is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1979-08-10 under 510(k) number K790848. The device is classified under product code KLI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-GENT QUANTICHROM T4 11A?

A-GENT QUANTICHROM T4 11A is a medical device that received FDA 510(k) clearance on 1979-08-10. The listed applicant is Abbott Laboratories. The 510(k) number is K790848.

When did A-GENT QUANTICHROM T4 11A receive FDA 510(k) clearance?

A-GENT QUANTICHROM T4 11A received FDA 510(k) clearance on 1979-08-10, under 510(k) number K790848.

Who is the listed applicant for A-GENT QUANTICHROM T4 11A?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-GENT QUANTICHROM T4 11A?

The FDA product code for A-GENT QUANTICHROM T4 11A is KLI.

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 Abbott Laboratories 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.

K262156Anti-HCV NextK252424Anti-HCV NextK243500ARCHITECT iGentamicinK243168Alinity i Rubella IgGK243283Alinity h-series SystemK233932Alinity i Toxo IgM

View all 876 devices →

Related Devices (Code: KLI)

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.

K160495VITROS® Automation SolutionsOrtho-Clinical Diagnostics, Inc.K131515ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENTAlfa WassermannK103484GSP NEONATAL THYROXINE (T4)Wallac Oy, A Subsidiary of Perkinelmer, Inc.K082638ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELLSiemens Healthcare Diagnostics, Inc.K030860ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300MonobindK023369ACCESS TOTAL T4 ASSAYBeckman Coulter, 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.

↑