Device Classification Name |
system, microbial growth monitor of normally sterile body fluid culture
|
510(k) Number |
K172412 |
Device Name |
BacterioScan 216Dx System |
Applicant |
BacterioScan, Inc. |
4041 Forest Park Ave. |
St. Louis,
MO
63108
|
|
Applicant Contact |
Rhonda Soest |
Correspondent |
MDC Associates, LLC. |
180 Cabot Street |
Beverly,
MA
01915
|
|
Correspondent Contact |
Fran White |
Regulation Number | 866.2560
|
Classification Product Code |
|
Date Received | 08/10/2017 |
Decision Date | 05/01/2018 |
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
|
|
|