Device Classification Name |
Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
|
510(k) Number |
K173725 |
Device Name |
NeuMoDx GBS Assay |
Applicant |
NeuMoDx Molecular, Inc. |
1250 Eisenhower Place |
Ann Arbor,
MI
48108
|
|
Applicant Contact |
Kay Fuller |
Correspondent |
Medical Device Regulatory Solutions, LLC |
230 Collingwood Dr. |
Suite 260 |
Ann Arbor,
MI
48103
|
|
Correspondent Contact |
Kay Fuller |
Regulation Number | 866.3740
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/05/2017 |
Decision Date | 06/26/2018 |
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
|
|
|