Diazyme EZ Vitamin D Assay
FDA 510(k) clearance K172992 · decided 2018-01-11
Clearance details
- K-number
- K172992
- Device name
- Diazyme EZ Vitamin D Assay
- Applicant
- Diazyme Laboratories
- Decision
- Substantially Equivalent
- Date received
- 2017-09-27
- Decision date
- 2018-01-11
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- MRG
- Device class
- 2
- Regulation number
- 862.1825
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Poway, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.