Device Classification Name |
Susceptibility Test Discs, Antimicrobial
|
510(k) Number |
K860153 |
Device Name |
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS |
Applicant |
OXOID U.S.A., INC. |
WADE RD. BASINGSTROKE |
HAMPSHIRE RG 24 OP,
GB
|
|
Applicant Contact |
E. Y BRIDSON |
Correspondent |
OXOID U.S.A., INC. |
WADE RD. BASINGSTROKE |
HAMPSHIRE RG 24 OP,
GB
|
|
Correspondent Contact |
E. Y BRIDSON |
Regulation Number | 866.1620
|
Classification Product Code |
|
Date Received | 01/15/1986 |
Decision Date | 03/04/1986 |
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
|
|
|