Device Classification Name |
System, Multipurpose For In Vitro Coagulation Studies
|
510(k) Number |
K760594 |
Device Name |
AUTO-FI COAGULATION INSTRUMENT |
Applicant |
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.5425
|
Classification Product Code |
|
Date Received | 09/07/1976 |
Decision Date | 11/24/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|