FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMIT 2000 VANCOMYCIN ASSAY
K Number: K020692
·
Decision May 10, 2002
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
30
Applicant Total
343
Review Days
67
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Basic Information
- Device Name
- EMIT 2000 VANCOMYCIN ASSAY
- K Number
- K020692
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3950
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- March 4, 2002
- Decision Date
- May 10, 2002
- Product Code
- LEH
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LEH | Radioimmunoassay, Vancomycin | FDA class 2 | Clinical Toxicology |
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IMMULITE 2000, IMMULITE 2500 VANCOMYCIN
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