Device Classification Name |
single (specified) analyte controls (assayed and unassayed)
|
510(k) Number |
K823353 |
Device Name |
CARCINO-CEK |
Applicant |
BIOLOGICS INTL., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BIOLOGICS INTL., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 11/09/1982 |
Decision Date | 12/14/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|