Device Classification Name |
slides, microscope
|
510(k) Number |
K813242 |
Device Name |
QUANTIMETRIC 2 TEST KIT |
Applicant |
KALLESTAD LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
KALLESTAD LABORATORIES, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.3010
|
Classification Product Code |
|
Date Received | 11/17/1981 |
Decision Date | 12/02/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Pathology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|