Cleared Traditional

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

K223690 · Shenzhen Yhlo Biotech Co., Ltd. · Chemistry

Dec 2023

Decision

367d

Days

Class 2

Risk

About This 510(k) Submission

K223690 is an FDA 510(k) clearance for the iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C), a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Shenzhen Yhlo Biotech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 11, 2023, 367 days after receiving the submission on December 9, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number	K223690 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 09, 2022
Decision Date	December 11, 2023
Days to Decision	367 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF