Device Classification Name |
test, time, prothrombin
|
510(k) Number |
K020831 |
Device Name |
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
JENNIFER TRIBBETT |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
P.O. BOX 50457 |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
JENNIFER TRIBBETT |
Regulation Number | 864.7750
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/14/2002 |
Decision Date | 10/24/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|