Cleared Traditional

MAGLUMI 2000 HCG/?-HCG

K192547 · Shenzhen New Industries Biomedical Engineering Co., Ltd. · Chemistry
Jan 2020
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K192547 is an FDA 510(k) clearance for the MAGLUMI 2000 HCG/?-HCG, a System, Test, Human Chorionic Gonadotropin (Class II — Special Controls, product code DHA), submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 17, 2020, 122 days after receiving the submission on September 17, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number K192547 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2019
Decision Date January 17, 2020
Days to Decision 122 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DHA — System, Test, Human Chorionic Gonadotropin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1155

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