Device Classification Name |
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
|
510(k) Number |
K170413 |
Device Name |
BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set |
Applicant |
Bio-Rad Laboratories |
5500 E. 2nd Street |
Benicia,
CA
94510
|
|
Applicant Contact |
Juang Wang |
Correspondent |
Bio-Rad Laboratories |
5500 E. 2nd Street |
Benicia,
CA
94510
|
|
Correspondent Contact |
Juang Wang |
Regulation Number | 866.3830
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/10/2017 |
Decision Date | 05/11/2017 |
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
|
Recalls |
CDRH Recalls
|
|
|