FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADVIA 1650 CHOLINESTERASE ASSAY
K Number: K013750
·
Decision Jan 18, 2002
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
32
Review Days
66
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Basic Information
- Device Name
- ADVIA 1650 CHOLINESTERASE ASSAY
- K Number
- K013750
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3240
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Diagnostics Corp.
- Date Received
- November 13, 2001
- Decision Date
- January 18, 2002
- Product Code
- DIH
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DIH | Colorimetry, Cholinesterase | FDA class 1 | Clinical Toxicology |
Similar 510(k) Clearances
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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 |