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)

TDXR REA(TM) ETHANOL

K-Number: K871645 · 1987-06-11

ApplicantAbbott Laboratories
Decision Date1987-06-11
Product CodeDIC
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TDXR REA(TM) ETHANOL is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1987-06-11 under 510(k) number K871645. The device is classified under product code DIC. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDXR REA(TM) ETHANOL?

TDXR REA(TM) ETHANOL is a medical device that received FDA 510(k) clearance on 1987-06-11. The listed applicant is Abbott Laboratories. The 510(k) number is K871645.

When did TDXR REA(TM) ETHANOL receive FDA 510(k) clearance?

TDXR REA(TM) ETHANOL received FDA 510(k) clearance on 1987-06-11, under 510(k) number K871645.

Who is the listed applicant for TDXR REA(TM) ETHANOL?

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 TDXR REA(TM) ETHANOL?

The FDA product code for TDXR REA(TM) ETHANOL is DIC.

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: DIC)

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.

K250609Sober Self-TestSober Ip, LLCK181553Immunalysis Ethyl Alcohol Enzyme AssayImmunalysis CorporationK121247ALCO-SCREENChematics, Inc.K121256ALCO-SCREEN 02Chematics, Inc.K111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALMedica Corp.K111206TECO DIAGNOSTICS SALIVA ALCOHOL TESTTeco Diagnostics

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.

↑