FDA 510(k) Application Details - K980596

Device Classification Name	Epstein-Barr Virus, Other   More FDA Info for this Device
510(K) Number	K980596
Device Name	Epstein-Barr Virus, Other
Applicant	CLARK LABORATORIES, INC. 1306F BAILES LN. FREDERICK, MD 21701 US Other 510(k) Applications for this Company
Contact	WILLIAM L BOTELER, JR. Other 510(k) Applications for this Contact
Regulation Number	866.3235   More FDA Info for this Regulation Number
Classification Product Code	LSE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/1998
Decision Date	07/22/1998
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