FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
K Number: K123320
·
Decision Feb 15, 2013
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
29
Applicant Total
92
Review Days
112
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Basic Information
- Device Name
- DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
- K Number
- K123320
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1065
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Healthcare Diagnostics
- Date Received
- October 26, 2012
- Decision Date
- February 15, 2013
- Product Code
- JIF
- 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 |
|---|---|---|---|
| JIF | Enzymatic Method, Ammonia | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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