Device Classification Name |
antiserum, positive control, aspergillus spp.
|
510(k) Number |
K760835 |
Device Name |
ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) |
Applicant |
I M, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
I M, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 866.3040
|
Classification Product Code |
|
Date Received | 10/13/1976 |
Decision Date | 11/01/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Immunology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|