Device Classification Name |
system, analysis, electrophoretic hemoglobin
|
510(k) Number |
K991362 |
Device Name |
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO) |
Applicant |
MORAX |
13805 WATERLOO RD. |
CHELSEA,
MI
48118
|
|
Applicant Contact |
BOREK JANIK |
Correspondent |
MORAX |
13805 WATERLOO RD. |
CHELSEA,
MI
48118
|
|
Correspondent Contact |
BOREK JANIK |
Regulation Number | 864.7440
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/14/1999 |
Decision Date | 06/21/1999 |
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
|
|
|