Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113253
Device Classification Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
More FDA Info for this Device
510(K) Number
K113253
Device Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 HENDERSON DRIVE
WEST CALDWELL, NJ 07006 US
Other 510(k) Applications for this Company
Contact
HYMAN KATZ
Other 510(k) Applications for this Contact
Regulation Number
862.2160
More FDA Info for this Regulation Number
Classification Product Code
JJE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/02/2011
Decision Date
05/17/2012
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