Device Classification Name |
Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens
|
510(k) Number |
K160911 |
Device Name |
VIDAS B.R.A.H.M.S. PCT (PCT) |
Applicant |
bioMerieux, Inc |
595 Anglum Rd. |
Hazelwood,
MO
63042
|
|
Applicant Contact |
Thi My Lan Dang |
Correspondent |
bioMerieux, Inc |
595 Anglum Rd. |
Hazelwood,
MO
63042
|
|
Correspondent Contact |
Thi My Lan Dang |
Regulation Number | 866.3215
|
Classification Product Code |
|
Date Received | 04/01/2016 |
Decision Date | 06/28/2016 |
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
|
|
|