510(k) K042189
- Device
- DIAZYME SODIUM ENZYMATIC ASSAY
- Applicant
- DIAZYME LABORATORIES
- 510(k) number
- K042189
- Product code
- MZU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-10-07
- Date received
- 2004-08-12
- Regulation
- 862.1665
- Classification name
- System, Test, Sodium, Enzymatic Method
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HUHAN TRAN
- Address
- 3550 General Atomics Ct. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3021841051
- 3003593973
- 2032900
Source Documents#
Other 510(k) Records For Product Code MZU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K082763 | DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114B | Diazyme Laboratories | 2008-11-12 |
Legacy Summary#
summary
FDA Review#
Decision Summary