Device Classification Name |
Multi-Analyte Controls, All Kinds (Assayed)
|
510(k) Number |
K102700 |
Device Name |
LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS |
Applicant |
ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN |
9975 Summers Ridge Road |
San Diego,
CA
92121
|
|
Applicant Contact |
EDWARD BREHM |
Correspondent |
ALERE, SAN DIEGO, DBA BIOSITE INCORPORATED, DBA IN |
9975 Summers Ridge Road |
San Diego,
CA
92121
|
|
Correspondent Contact |
EDWARD BREHM |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 09/20/2010 |
Decision Date | 12/21/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|