Device Classification Name |
radioimmunoassay, estradiol
|
510(k) Number |
K954697 |
Device Name |
CIBA CORNING ACS ESTRADIOL-6 ASSAY |
Applicant |
CIBA CORNING DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052 -1688
|
|
Applicant Contact |
STEVEN R RAKITIN |
Correspondent |
CIBA CORNING DIAGNOSTICS CORP. |
63 NORTH ST. |
MEDFIELD,
MA
02052 -1688
|
|
Correspondent Contact |
STEVEN R RAKITIN |
Regulation Number | 862.1260
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/12/1995 |
Decision Date | 12/13/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|