Device Classification Name |
lead, atomic absorption
|
510(k) Number |
K123563 |
Device Name |
LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM |
Applicant |
MAGELLAN DIAGNOSTICS |
101 BILLERICA AVE. |
BLDG #4 |
NORTH BILLERICA,
MA
01862 -1271
|
|
Applicant Contact |
STUART NAYLOR |
Correspondent |
MAGELLAN DIAGNOSTICS |
101 BILLERICA AVE. |
BLDG #4 |
NORTH BILLERICA,
MA
01862 -1271
|
|
Correspondent Contact |
STUART NAYLOR |
Regulation Number | 862.3550
|
Classification Product Code |
|
Date Received | 11/19/2012 |
Decision Date | 08/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|