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FDA 510(k)

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)

K-Number: K223690 · 2023-12-11

ApplicantShenzhen Yhlo Biotech Co., Ltd.
Decision Date2023-12-11
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Yhlo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-12-11 under 510(k) number K223690. 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 iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is a medical device that received FDA 510(k) clearance on 2023-12-11. The listed applicant is Shenzhen Yhlo Biotech Co., Ltd.. The 510(k) number is K223690.

When did iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) receive FDA 510(k) clearance?

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) received FDA 510(k) clearance on 2023-12-11, under 510(k) number K223690.

Who is the listed applicant for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

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

What is the FDA product code for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

The FDA product code for iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is DHA.

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 DiagnosticsK230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott LaboratoriesK230790Alinity 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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