Device Classification Name |
manual antimicrobial susceptibility test systems
|
510(k) Number |
K190109 |
Device Name |
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) |
Applicant |
Beckman Coulter, Inc. |
1584 Enterprise Blvd. |
West Sacramento,
CA
95691
|
|
Applicant Contact |
Elaine Duncan |
Correspondent |
Beckman Coulter, Inc. |
1584 Enterprise Blvd. |
West Sacramento,
CA
95691
|
|
Correspondent Contact |
Elaine Duncan |
Regulation Number | 866.1640
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/23/2019 |
Decision Date | 04/18/2019 |
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
|
|
|