Device Classification Name |
Procalcitonin Assay
|
510(k) Number |
K171338 |
Device Name |
B R A H M S PCT sensitive KRYPTOR |
Applicant |
B.R.A.H.M.S GmbH |
Neuendorfstr. 25 |
Hennigsdorf,
DE
16761
|
|
Applicant Contact |
Sascha Johannes |
Correspondent |
B.R.A.H.M.S GmbH |
Neuendorfstr. 25 |
Hennigsdorf,
DE
16761
|
|
Correspondent Contact |
Bernhard Ciommer |
Regulation Number | 866.3215
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/08/2017 |
Decision Date | 05/31/2017 |
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
|
|
|