Device Classification Name |
System, Multipurpose For In Vitro Coagulation Studies
|
510(k) Number |
K974569 |
Device Name |
COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING |
Applicant |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Applicant Contact |
RICHARD NAPLES |
Correspondent |
BOEHRINGER MANNHEIM CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250 -0457
|
|
Correspondent Contact |
RICHARD NAPLES |
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 12/08/1997 |
Decision Date | 01/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|