Device Classification Name |
Electrophoretic, Lactate Dehydrogenase Isoenzymes
|
510(k) Number |
K842669 |
Device Name |
TITAN GEL ISO DOT LDH KIT |
Applicant |
HELENA LABORATORIES |
P.O. BOX 752 |
1530 LINDBERGH DRIVE |
BEAUMONT,
TX
77704
|
|
Applicant Contact |
ERIC PETERSEN |
Correspondent |
HELENA LABORATORIES |
P.O. BOX 752 |
1530 LINDBERGH DRIVE |
BEAUMONT,
TX
77704
|
|
Correspondent Contact |
ERIC PETERSEN |
Regulation Number | 862.1445
|
Classification Product Code |
|
Date Received | 07/10/1984 |
Decision Date | 11/09/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|