FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
K Number: K121994
·
Decision Nov 30, 2012
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
77
Applicant Total
152
Review Days
147
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Basic Information
- Device Name
- DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
- K Number
- K121994
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1810
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Date Received
- July 6, 2012
- Decision Date
- November 30, 2012
- Product Code
- CDD
- 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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | FDA class 2 | Clinical Chemistry |
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