Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K020387
Device Classification Name
System, Test, Radioallergosorbent (Rast) Immunological
More FDA Info for this Device
510(K) Number
K020387
Device Name
System, Test, Radioallergosorbent (Rast) Immunological
Applicant
IMMUNETECH CORPORATION
P.O. BOX 9433
17394 VIA DEL BRAVO
RANCHO SANTA FE, CA 92067 US
Other 510(k) Applications for this Company
Contact
VIVIANNE NOETZEL
Other 510(k) Applications for this Contact
Regulation Number
866.5750
More FDA Info for this Regulation Number
Classification Product Code
DHB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/05/2002
Decision Date
04/17/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact