Device Classification Name |
manual antimicrobial susceptibility test systems
|
510(k) Number |
K870074 |
Device Name |
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS |
Applicant |
MICROSCAN DIV. BAXTER HEALTHCARE CORP. |
2040 ENTERPRISE BLVD. |
W. SACRAMENTO,
CA
95691
|
|
Applicant Contact |
LORRAINE WEAVER |
Correspondent |
MICROSCAN DIV. BAXTER HEALTHCARE CORP. |
2040 ENTERPRISE BLVD. |
W. SACRAMENTO,
CA
95691
|
|
Correspondent Contact |
LORRAINE WEAVER |
Regulation Number | 866.1640
|
Classification Product Code |
|
Date Received | 01/08/1987 |
Decision Date | 04/14/1987 |
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
|