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)

ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

K-Number: K982250 · 1998-07-14

ApplicantBeckman Instruments, Inc.
Decision Date1998-07-14
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1998-07-14 under 510(k) number K982250. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER?

ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is a medical device that received FDA 510(k) clearance on 1998-07-14. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K982250.

When did ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER receive FDA 510(k) clearance?

ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER received FDA 510(k) clearance on 1998-07-14, under 510(k) number K982250.

Who is the listed applicant for ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER?

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

What is the FDA product code for ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER?

The FDA product code for ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is CEC.

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 Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229K974564IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT

View all 281 devices →

Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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.

↑