FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
K Number: K123563
·
Decision Aug 20, 2013
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
5
Applicant Total
2
Review Days
274
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Basic Information
- Device Name
- LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
- K Number
- K123563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3550
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Magellan Diagnostics
- Date Received
- November 19, 2012
- Decision Date
- August 20, 2013
- 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 Magellan Diagnostics
| K Number | Device Name | ||
|---|---|---|---|
| K142705 | LeadCare Plus Blood Lead Testing System | Jul 7, 2015 | Substantially Equivalent |