FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
K Number: K964587
·
Decision Jan 13, 1997
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
30
Applicant Total
96
Review Days
59
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Basic Information
- Device Name
- VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM
- K Number
- K964587
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3950
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- November 15, 1996
- Decision Date
- January 13, 1997
- 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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