Device Classification Name |
Electrophoretic, Protein Fractionation
|
510(k) Number |
K913058 |
Device Name |
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 |
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 | 862.1630
|
Classification Product Code |
|
Date Received | 07/10/1991 |
Decision Date | 10/30/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|