MAGLUMI 2000 HCG/ß-HCG
FDA 510(k) clearance K192547 · decided 2020-01-17
Clearance details
- K-number
- K192547
- Device name
- MAGLUMI 2000 HCG/ß-HCG
- Applicant
- Shenzhen New Industries Biomedical Engineering Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2019-09-17
- Decision date
- 2020-01-17
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- DHA
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.