Device Classification Name |
Culture Media, Non-Propagating Transport
|
510(k) Number |
K965152 |
Device Name |
A.C.T. II |
Applicant |
REMEL CO. |
12076 SANTA FE DR. |
LENEXA,
KS
66215
|
|
Applicant Contact |
MARY ANN SILVIUS |
Correspondent |
REMEL CO. |
12076 SANTA FE DR. |
LENEXA,
KS
66215
|
|
Correspondent Contact |
MARY ANN SILVIUS |
Regulation Number | 866.2390
|
Classification Product Code |
|
Date Received | 12/23/1996 |
Decision Date | 01/22/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|