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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

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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