FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESA LEADCARE II LEAD CONTROL
K Number: K063398
·
Decision Dec 5, 2006
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
49
Review Days
26
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Basic Information
- Device Name
- ESA LEADCARE II LEAD CONTROL
- K Number
- K063398
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionostics, Inc.
- Date Received
- November 9, 2006
- Decision Date
- December 5, 2006
- Product Code
- DIF
- 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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