Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Alinity i Total ß-hCG Reagent Kit, GLP systems Track

K-Number: K230937 · 2023-06-05

ApplicantAbbott Laboratories
Decision Date2023-06-05
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Alinity i Total ß-hCG Reagent Kit, GLP systems Track is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2023-06-05 under approval number K230937. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

Alinity i Total ß-hCG Reagent Kit, GLP systems Track is a medical device that received FDA 510(k) clearance on 2023-06-05. It is manufactured by Abbott Laboratories. The 510(k) number is K230937.

When was Alinity i Total ß-hCG Reagent Kit, GLP systems Track approved by the FDA?

Alinity i Total ß-hCG Reagent Kit, GLP systems Track received FDA 510(k) clearance on 2023-06-05, under approval number K230937.

What company makes Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

Alinity i Total ß-hCG Reagent Kit, GLP systems Track is manufactured by Abbott Laboratories.

What is the FDA product code for Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

The FDA product code for Alinity i Total ß-hCG Reagent Kit, GLP systems Track is DHA.

Related Clinical Trials

NCT06420323 NovoX®Cup as Primary Dressing After Breast Reduction ACTIVE_NOT_RECRUITING NCT06539936 Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses RECRUITING NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT07557147 Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor NOT_YET_RECRUITING NCT06668402 Study of Daily Step Count and Treatment Response in Rectal Cancer (STEP-R) COMPLETED NCT07207356 Ultrasound Guided Transcutaneous Pulsed Radiofrequency for Cervical Radiculopathy RECRUITING

Other Devices by Abbott Laboratories

K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control K173122Abbott Architect Free T4 K170320Alinity c ICT Sample Diluent K170317Alinity i Total ß-hCG Reagent Kit, Alinity i System K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM

View all 34 devices →

Related Devices (Code: DHA)

K170317Alinity i Total ß-hCG Reagent Kit, Alinity i SystemAbbott Laboratories K163418Diazyme DZ-Lite Total beta-hCG Test SystemDiazyme Laboratories K192790Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc. K192547MAGLUMI 2000 HCG/ß-HCGShenzhen New Industries Biomedical Engineering Co., Ltd. K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme Laboratories, Inc. K203227Elecsys HCG STATRoche 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.

↑