FDA 510(k)
FDA class 1
Substantially Equivalent
🇨🇦 Canada
MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
K Number: K063208
·
Decision Jan 19, 2007
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
89
Applicant Total
66
Review Days
88
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Basic Information
- Device Name
- MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
- K Number
- K063208
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Diagnostic Chemicals , Ltd.
- Date Received
- October 23, 2006
- Decision Date
- January 19, 2007
- Product Code
- JGJ
- 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 |
|---|---|---|---|
| JGJ | Photometric Method, Magnesium | FDA class 1 | Clinical Chemistry |
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