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510(k) K223690

iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) by Shenzhen Yhlo Biotech Co., Ltd. — Product Code DHA

K223690 is an FDA 510(k) premarket notification submitted by Shenzhen Yhlo Biotech Co., Ltd. for the device "iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)". The FDA issued a decision of Substantially Equivalent on December 11, 2023. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2023
Date Received
December 9, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Human Chorionic Gonadotropin
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

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FDA data resources