Device Classification Name |
chromatographic separation, lactate dehydrogenase isoenzymes
|
510(k) Number |
K851521 |
Device Name |
LD-1(IMMUNO) SEPARATION SET |
Applicant |
SERAGEN DIAGNOSTICS, INC. |
P.O. BOX 1210 |
INDIANAPOLIS,
IN
46206
|
|
Applicant Contact |
MICHAEL J SULLIVAN |
Correspondent |
SERAGEN DIAGNOSTICS, INC. |
P.O. BOX 1210 |
INDIANAPOLIS,
IN
46206
|
|
Correspondent Contact |
MICHAEL J SULLIVAN |
Regulation Number | 862.1445
|
Classification Product Code |
|
Date Received | 04/15/1985 |
Decision Date | 05/10/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|