Diazyme 1,5-AG Assay— 510(k) K180209
Substantially EquivalentDiazyme Laboratories, Inc.
FDA 510(k) clearance K180209 for Diazyme 1,5-AG Assay, Substantially Equivalent on 2018-10-04. Applicant: Diazyme Laboratories, Inc..
Clearance details
- Applicant
- Diazyme Laboratories, Inc.
- Product code
- Code NOZ
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
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