510(k) K053566
- Device
- MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
- Applicant
- DIAZYME LABORATORIES
- 510(k) number
- K053566
- Product code
- MZV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-02-15
- Date received
- 2005-12-22
- Regulation
- 862.1600
- Classification name
- Test, System, Potassium, Enzymatic Method
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HUAN 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 MZV #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200865 | Piccolo Potassium Test System | Abaxis, Inc. | 2021-10-20 |
| K091455 | DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL | Diazyme Laboratories | 2009-08-14 |
| K042191 | DIAZYME POTASSIUM ENZYMATIC ASSAY KIT | Diazyme Laboratories | 2004-10-29 |
Legacy Summary#
summary
FDA Review#
Decision Summary