Device Classification Name |
lead, atomic absorption
|
510(k) Number |
K142705 |
Device Name |
LeadCare Plus Blood Lead Testing System |
Applicant |
Magellan Diagnostics |
101 Billerica Ave. Bldg #4 |
North Billerica,
MA
01862
|
|
Applicant Contact |
Reba Daoust |
Correspondent |
Magellan Diagnostics |
101 Billerica Ave. Bldg #4 |
North Billerica,
MA
01862
|
|
Correspondent Contact |
Reba Daoust |
Regulation Number | 862.3550
|
Classification Product Code |
|
Date Received | 09/22/2014 |
Decision Date | 07/07/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|