Device Classification Name |
Culture Media, Selective And Non-Differential
|
510(k) Number |
K820805 |
Device Name |
#2005 SABOURAUD DEXTROSE AGAR/#4002 SLA |
Applicant |
BIOMEDICA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BIOMEDICA, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 866.2360
|
Classification Product Code |
|
Date Received | 03/23/1982 |
Decision Date | 04/08/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|