Device Classification Name |
system, test, automated, antimicrobial susceptibility, short incubation
|
510(k) Number |
K031602 |
Device Name |
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) |
Applicant |
DADE BEHRING, INC. |
2040 ENTERPRISE BLVD. |
WEST SACRAMENTO,
CA
95691
|
|
Applicant Contact |
ROBERT EUSEBIO |
Correspondent |
DADE BEHRING, INC. |
2040 ENTERPRISE BLVD. |
WEST SACRAMENTO,
CA
95691
|
|
Correspondent Contact |
ROBERT EUSEBIO |
Regulation Number | 866.1645
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/21/2003 |
Decision Date | 07/31/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|