Device Classification Name |
test, time, prothrombin
|
510(k) Number |
K122584 |
Device Name |
HEMOSIL READIPLAS TIN |
Applicant |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Applicant Contact |
Jacqueline Emery |
Correspondent |
INSTRUMENTATION LABORATORY CO. |
180 HARTWELL ROAD |
BEDFORD,
MA
01730
|
|
Correspondent Contact |
Jacqueline Emery |
Regulation Number | 864.7750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/24/2012 |
Decision Date | 03/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|