Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K960274
Device Classification Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
More FDA Info for this Device
510(K) Number
K960274
Device Name
Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Applicant
ORGENTEC
P.O. BOX 451
WINDHAM, NH 03087 US
Other 510(k) Applications for this Company
Contact
RICHARD CONLEY
Other 510(k) Applications for this Contact
Regulation Number
862.1645
More FDA Info for this Regulation Number
Classification Product Code
JIR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/19/1996
Decision Date
03/29/1996
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