FDA 510(k) Application Details - K003195

Device Classification Name	More FDA Info for this Device
510(K) Number	K003195
Device Name	GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
Applicant	GREER LABORATORIES, INC. 639 NUWAY CIRCLE, N.E. P.O. BOX 800 LENOIR, NC 28645-0800 US Other 510(k) Applications for this Company
Contact	GERALD FRIESEN 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	10/12/2000
Decision Date	12/13/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review