FDA 510(k) Application Details - K960759

Device Classification Name	Kit, Identification, Neisseria Gonorrhoeae   More FDA Info for this Device
510(K) Number	K960759
Device Name	Kit, Identification, Neisseria Gonorrhoeae
Applicant	MEDTEX LABORATORIES, INC. 10215 LAKE CITY WAY, N.E. SUITE F SEATTLE, WA 98125 US Other 510(k) Applications for this Company
Contact	KIRK C S. CHEN Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/1996
Decision Date	09/18/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review