FDA 510(k) Application Details - K971857

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Mumps Virus   More FDA Info for this Device
510(K) Number	K971857
Device Name	Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Applicant	GULL LABORATORIES, INC. 1011 MURRAY HOLLADAY RD. SALT LAKE CITY, UT 84117 US Other 510(k) Applications for this Company
Contact	FRED W RACHFORD Other 510(k) Applications for this Contact
Regulation Number	866.3380   More FDA Info for this Regulation Number
Classification Product Code	LJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/1997
Decision Date	11/04/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review