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)

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK

K-Number: K974027 · 1998-02-02

ApplicantAlfa Biotech (Uk) , Ltd.
Decision Date1998-02-02
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK is the device name listed in this FDA 510(k) record. The listed applicant is Alfa Biotech (Uk) , Ltd.. It received FDA 510(k) clearance on 1998-02-02 under 510(k) number K974027. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK?

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK is a medical device that received FDA 510(k) clearance on 1998-02-02. The listed applicant is Alfa Biotech (Uk) , Ltd.. The 510(k) number is K974027.

When did AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK receive FDA 510(k) clearance?

AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK received FDA 510(k) clearance on 1998-02-02, under 510(k) number K974027.

Who is the listed applicant for AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK?

The FDA 510(k) record lists Alfa Biotech (Uk) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK?

The FDA product code for AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK is CDP.

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 Alfa Biotech (Uk) , Ltd. 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.

K980574AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0K974505AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501

Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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.

↑