Device Classification Name |
reagent, platelet aggregation
|
510(k) Number |
K910706 |
Device Name |
COLLAGEN REAGENT CAT. NO. 5368 |
Applicant |
HELENA LABORATORIES |
1530 LINDBERGH DR. |
P.O. BOX 752 |
BEAUMONT,
TX
77704
|
|
Applicant Contact |
PAT FRANKS |
Correspondent |
HELENA LABORATORIES |
1530 LINDBERGH DR. |
P.O. BOX 752 |
BEAUMONT,
TX
77704
|
|
Correspondent Contact |
PAT FRANKS |
Regulation Number | 864.5700
|
Classification Product Code |
|
Date Received | 02/20/1991 |
Decision Date | 05/20/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|