MAGLUMI 2000 HCG/ß-HCG
K-Number: K192547 · 2020-01-17
Decision Date2020-01-17
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
MAGLUMI 2000 HCG/ß-HCG is a medical device manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. It received FDA 510(k) clearance on 2020-01-17 under approval number K192547. 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 MAGLUMI 2000 HCG/ß-HCG?
MAGLUMI 2000 HCG/ß-HCG is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd.. The 510(k) number is K192547.
When was MAGLUMI 2000 HCG/ß-HCG approved by the FDA?
MAGLUMI 2000 HCG/ß-HCG received FDA 510(k) clearance on 2020-01-17, under approval number K192547.
What company makes MAGLUMI 2000 HCG/ß-HCG?
MAGLUMI 2000 HCG/ß-HCG is manufactured by Shenzhen New Industries Biomedical Engineering Co., Ltd..
What is the FDA product code for MAGLUMI 2000 HCG/ß-HCG?
The FDA product code for MAGLUMI 2000 HCG/ß-HCG is DHA.
Other Devices by Shenzhen New Industries Biomedical Engineering Co., Ltd.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.