Device Classification Name |
culture media, selective and differential
|
510(k) Number |
K822737 |
Device Name |
MYCOTRIUM-RS |
Applicant |
HANA BIOLOGICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
HANA BIOLOGICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 866.2360
|
Classification Product Code |
|
Date Received | 09/09/1982 |
Decision Date | 12/03/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|