LEADCARE II BLOOD LEAD TESTING SYSTEM
FDA 510(k) clearance K052549 · decided 2005-10-06
Clearance details
- K-number
- K052549
- Device name
- LEADCARE II BLOOD LEAD TESTING SYSTEM
- Applicant
- Esa Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-16
- Decision date
- 2005-10-06
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- DOF
- Device class
- 2
- Regulation number
- 862.3550
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Chelmsford, MA, US
- Third-party review
- No
- Expedited review
- No
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