FDA 510(k) Application Details - K992252

Device Classification Name	Pneumocystis Carinii   More FDA Info for this Device
510(K) Number	K992252
Device Name	Pneumocystis Carinii
Applicant	CHEMICON INTL., INC. 28835 SINGLE OAK DR. TEMECULA, CA 92590 US Other 510(k) Applications for this Company
Contact	CINDY PENNY Other 510(k) Applications for this Contact
Regulation Number	866.3780   More FDA Info for this Regulation Number
Classification Product Code	LYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/1999
Decision Date	08/10/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review