FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Ammonia II
K Number: K183517
·
Decision Feb 8, 2019
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
29
Applicant Total
14
Review Days
52
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Basic Information
- Device Name
- Ammonia II
- K Number
- K183517
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1065
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Roche Diagnostics Operations (Rdo)
- Date Received
- December 18, 2018
- Decision Date
- February 8, 2019
- 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.
DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)
FDA 510(k)
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DIMENSION AMMONIA FLEX REAGENT CARTRIDGE
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DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE
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SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY
FDA 510(k)
FDA Class 1
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AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RANDOX AMMONIA
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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