Device Classification Name |
Manual Antimicrobial Susceptibility Test Systems
|
510(k) Number |
K042331 |
Device Name |
PASCO MIC AND MIC/ID PANELS |
Applicant |
PASCO LABORATORIES, INC. |
12750 WEST 42ND AVE. |
WHEAT RIDGE,
CO
80033
|
|
Applicant Contact |
LINDA K DILLON |
Correspondent |
PASCO LABORATORIES, INC. |
12750 WEST 42ND AVE. |
WHEAT RIDGE,
CO
80033
|
|
Correspondent Contact |
LINDA K DILLON |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 08/30/2004 |
Decision Date | 10/07/2004 |
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
|
|
|