FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K Number: K021151
·
Decision Jul 13, 2002
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
29
Applicant Total
32
Review Days
94
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Basic Information
- Device Name
- AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
- K Number
- K021151
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1065
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Diagnostics Corp.
- Date Received
- April 10, 2002
- Decision Date
- July 13, 2002
- 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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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
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AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Bayer Diagnostics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K033379 | BAYER SPECIAL CHEMISTRY CONTROLS | Dec 19, 2003 | Substantially Equivalent |
| K033380 | BAYER SPECIAL CHEMISTRY CALIBRATORS | Dec 16, 2003 | Substantially Equivalent |
| K033007 | BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM | Nov 14, 2003 | Substantially Equivalent |
| K031857 | ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY | Sep 4, 2003 | Substantially Equivalent |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Mar 18, 2003 | Substantially Equivalent |
| K030452 | BAYER LIGAND PLUS 1, 2, 3 CONTROLS | Mar 3, 2003 | Substantially Equivalent |
| K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | Jan 7, 2003 | Substantially Equivalent |
| K023841 | AMMONIA ASSAY FOR THE ADVIA 1650 | Dec 24, 2002 | Substantially Equivalent |
| K022177 | PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Dec 17, 2002 | Substantially Equivalent |
| K022329 | CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Nov 27, 2002 | Substantially Equivalent |