FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
K Number: K062316
·
Decision Sep 6, 2006
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
29
Applicant Total
343
Review Days
28
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Basic Information
- Device Name
- DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
- K Number
- K062316
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1065
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- August 9, 2006
- Decision Date
- September 6, 2006
- 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
Other 510(k) clearances with the same product code (JIF), ordered by most recent decision date.
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SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
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AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
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RANDOX AMMONIA
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