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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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-06-05 under 510(k) 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. The listed applicant is Abbott Laboratories. The 510(k) number is K230937.

When did Alinity i Total ß-hCG Reagent Kit, GLP systems Track receive FDA 510(k) clearance?

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

Who is the listed applicant for Alinity i Total ß-hCG Reagent Kit, GLP systems Track?

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 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.

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.

PMA P120008KIT, TEST, ALPHA-FETOPROTEIN FOR NEURAL TUBE DEFECTSK252424Anti-HCV NextPMA P910007Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerPMA P980007Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditionsK243500ARCHITECT iGentamicinK243168Alinity i Rubella IgG

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Related Devices (Code: DHA)

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.

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical DiagnosticsK223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.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.

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