FDA 510(k) Application Details - K000299

Device Classification Name	More FDA Info for this Device
510(K) Number	K000299
Device Name	DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D
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	More FDA Info for this Regulation Number
Classification Product Code	SCL 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	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review