Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K110605
Device Classification Name
Immunoassay, Placental Alpha-1 Microglobulin (Pamg-1)
More FDA Info for this Device
510(K) Number
K110605
Device Name
Immunoassay, Placental Alpha-1 Microglobulin (Pamg-1)
Applicant
CLINICAL INNOVATIONS, LLC
747 WEST 4170 SOUTH
MURRAY, UT 84123 US
Other 510(k) Applications for this Company
Contact
DEAN WALLACE
Other 510(k) Applications for this Contact
Regulation Number
862.1550
More FDA Info for this Regulation Number
Classification Product Code
NQM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/02/2011
Decision Date
11/23/2011
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