Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Device Classification Under Section 513(f)(2)(De Novo)
FDA Home
Medical Devices
Databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
Back to Search Results
Device Classification Name
device to detect and measure procalcitonin (pct) in human clinical specimens
De Novo Number
DEN150009
Device Name
B.R.A.H.M.S PCT sensitive KRYPTOR
Requester
b.r.a.h.m.s gmbh
neuendorfstr. 25
hennigsdorf, DE 16761
Contact
bernhard ciommer
Regulation Number
866.3215
Classification Product Code
PMT
Date Received
03/04/2015
Decision Date
02/20/2016
Decision
granted (DENG)
Classification Advisory Committee
Microbiology
Review Advisory Committee
Microbiology
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Direct
-
-