Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K933722
Device Classification Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
More FDA Info for this Device
510(K) Number
K933722
Device Name
Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Applicant
HORIZON DIAGNOSTICS, INC.
3660 PLAZA DRIVE,STE.4
ANN ARBOR, MI 48108 US
Other 510(k) Applications for this Company
Contact
DAVID CALLENDER
Other 510(k) Applications for this Contact
Regulation Number
862.1705
More FDA Info for this Regulation Number
Classification Product Code
CDT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/02/1993
Decision Date
06/13/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact