FDA 510(k) Application Details - K981391

Device Classification Name	Device, Specimen Collection   More FDA Info for this Device
510(K) Number	K981391
Device Name	Device, Specimen Collection
Applicant	REMEL, INC. 12076 SANTA FE DR. LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	MARY ANN SILVIUS Other 510(k) Applications for this Contact
Regulation Number	866.2900   More FDA Info for this Regulation Number
Classification Product Code	LIO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/1998
Decision Date	07/14/1998
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