MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer— 510(k) K162698
Substantially EquivalentShenzhen New Industries Biomedical Engineering Co., Ltd.
FDA 510(k) clearance K162698 for MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer, Substantially Equivalent on 2017-07-14. Applicant: Shenzhen New Industries Biomedical Engineering Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Product code
- Code JLW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1690
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
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More clearances from Shenzhen New Industries Biomedical Engineering Co., Ltd.
view allAdverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.