FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
K Number: K091455
·
Decision Aug 14, 2009
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
41
Review Days
88
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Basic Information
- Device Name
- DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL
- K Number
- K091455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1600
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories
- Date Received
- May 18, 2009
- Decision Date
- August 14, 2009
- Product Code
- MZV
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MZV | Test, System, Potassium, Enzymatic Method | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MZV), ordered by most recent decision date.
Piccolo Potassium Test System
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MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DIAZYME POTASSIUM ENZYMATIC ASSAY KIT
FDA 510(k)
FDA Class 2
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