Device Classification Name |
antinuclear antibody, indirect immunofluorescent, antigen, control
|
510(k) Number |
K813592 |
Device Name |
QUANTAFLUOR FLUORESCENT TEST REAGENTS |
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 | 866.5100
|
Classification Product Code |
|
Date Received | 12/28/1981 |
Decision Date | 01/18/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Immunology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|