Device Classification Name |
Radioassay, Vitamin B12
|
510(k) Number |
K760946 |
Device Name |
B12/FOLATE SING. TUBE DUAL RADIOASSAY KT |
Applicant |
SCHWARZ MANN |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SCHWARZ MANN |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1810
|
Classification Product Code |
|
Date Received | 11/01/1976 |
Decision Date | 12/21/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|