Device Classification Name |
radioassay, vitamin b12
|
510(k) Number |
K840462 |
Device Name |
VITAMIN B12 57CO/FOLATE 125I - |
Applicant |
CORNING MEDICAL & SCIENTIFIC |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
CORNING MEDICAL & SCIENTIFIC |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1810
|
Classification Product Code |
|
Date Received | 02/02/1984 |
Decision Date | 06/25/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|