FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
K Number: K121907
·
Decision Jul 23, 2012
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
92
Review Days
24
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Basic Information
- Device Name
- DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
- K Number
- K121907
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- June 29, 2012
- Decision Date
- July 23, 2012
- Product Code
- CJO
- 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 |
|---|---|---|---|
| CJO | Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CJO), ordered by most recent decision date.
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FDA 510(k)
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FDA 510(k)
FDA Class 2
·Clinical Chemistry
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