FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
K Number: K082001
·
Decision Dec 5, 2008
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
41
Review Days
144
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Basic Information
- Device Name
- DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
- K Number
- K082001
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3560
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diazyme Laboratories
- Date Received
- July 14, 2008
- Decision Date
- December 5, 2008
- Product Code
- JII
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| JII | Atomic Absorption, Lithium | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JII), ordered by most recent decision date.
DIAZYME LITHIUM ENZYMATIC ASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
UROTEST GPH
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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