FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEADCARE II BLOOD LEAD TESTING SYSTEM
K Number: K052549
·
Decision Oct 6, 2005
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
2
Review Days
20
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Basic Information
- Device Name
- LEADCARE II BLOOD LEAD TESTING SYSTEM
- K Number
- K052549
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3550
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Esa Biosciences, Inc.
- Date Received
- September 16, 2005
- Decision Date
- October 6, 2005
- Product Code
- DOF
- 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 |
|---|---|---|---|
| DOF | Lead, Atomic Absorption | FDA class 2 | Clinical Toxicology |
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Other Clearances by Esa Biosciences, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072536 | ESA BIOSCIENCES INC. VITAMIN D HPLC TEST | May 7, 2008 | Substantially Equivalent |