FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K Number: K992662
·
Decision Feb 15, 2000
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
96
Review Days
190
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Basic Information
- Device Name
- 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
- K Number
- K992662
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- August 9, 1999
- Decision Date
- February 15, 2000
- Product Code
- MSJ
- 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 |
|---|---|---|---|
| MSJ | Apolipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSJ), ordered by most recent decision date.
DIAZYME APOLIPOPROTEIN A-1 ASSAY
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DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MODEL DZXXX
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APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
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·Clinical Chemistry
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
FDA 510(k)
FDA Class 1
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SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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|---|---|---|---|
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| K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM | Nov 20, 2002 | Substantially Equivalent |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Jul 24, 2002 | Substantially Equivalent |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | Jul 5, 2002 | Substantially Equivalent |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Mar 27, 2002 | Substantially Equivalent |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Dec 21, 2001 | Substantially Equivalent |