510(k) K180209
- Device
- Diazyme 1,5-AG Assay
- Applicant
- Diazyme Laboratories Inc.
- 510(k) number
- K180209
- Product code
- NOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-04
- Date received
- 2018-01-24
- Regulation
- 864.7470
- Classification name
- Assay, 1,5-anhydroglucitol (15ag)
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Abhijit Datta
- Address
- 12889 Gregg Ct. Poway CA US 92130 92130
FDA Registration Numbers#
- 2032900
- 3016698405
- 3002807722
Source Documents#
Other 510(k) Records For Product Code NOZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031604 | GLYCOMARK | Tomen America, Inc. | 2003-09-22 |
Legacy Summary#
summary
FDA Review#
Decision Summary