Device Classification Name |
system, multipurpose for in vitro coagulation studies
|
510(k) Number |
K060162 |
Device Name |
ACL ELITE; ACL ELITE PRO |
Applicant |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Applicant Contact |
CAROL MARBLE |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
CAROL MARBLE |
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 01/23/2006 |
Decision Date | 02/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|