Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K190490
Device Classification Name
Enzymatic Esterase--Oxidase, Cholesterol
More FDA Info for this Device
510(K) Number
K190490
Device Name
Enzymatic Esterase--Oxidase, Cholesterol
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626 US
Other 510(k) Applications for this Company
Contact
Alexandra Chamberlain
Other 510(k) Applications for this Contact
Regulation Number
862.1175
More FDA Info for this Regulation Number
Classification Product Code
CHH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/28/2019
Decision Date
03/27/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact