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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 a medical device manufactured by Shenzhen Yhlo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-12-11 under approval 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. It is manufactured by Shenzhen Yhlo Biotech Co., Ltd.. The 510(k) number is K223690.

When was iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) approved by the FDA?

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

What company makes iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)?

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) is manufactured by Shenzhen Yhlo Biotech Co., Ltd..

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)

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

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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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