510(k) K082763
- Device
- DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B
- Applicant
- DIAZYME LABORATORIES
- 510(k) number
- K082763
- Product code
- MZU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-11-12
- Date received
- 2008-09-22
- Regulation
- 862.1665
- Classification name
- System, Test, Sodium, Enzymatic Method
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Abhijit Datta
- Address
- 12889 Gregg Ct. Poway CA US 92064 92064
FDA Registration Numbers#
- 3021841051
- 3003593973
- 2032900
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MZU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K042189 | DIAZYME SODIUM ENZYMATIC ASSAY | Diazyme Laboratories | 2004-10-07 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Decision Summary