510(k) K031604
- Device
- GLYCOMARK
- Applicant
- TOMEN AMERICA INC.
- 510(k) number
- K031604
- Product code
- NOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-22
- Date received
- 2003-05-22
- 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
- Erika B Ammirati
- Address
- 1285 Ave. Of The Americas New York NY US 10019 10019
FDA Registration Numbers#
- 2032900
- 3016698405
- 3002807722
Source Documents#
Other 510(k) Records For Product Code NOZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180209 | Diazyme 1,5-AG Assay | Diazyme Laboratories, Inc. | 2018-10-04 |
Legacy Summary#
summary
FDA Review#
Decision Summary