FDA 510(k) Application Details - K000299

Device Classification Name	System, Delivery, Allergen And Vaccine   More FDA Info for this Device
510(K) Number	K000299
Device Name	System, Delivery, Allergen And Vaccine
Applicant	BIOMEDEX, INC. 3380 MISTLETOE RD. DALLAS, OR 97338 US Other 510(k) Applications for this Company
Contact	JAMES L THOMPSON Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LDH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/31/2000
Decision Date	04/28/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review