FDA 510(k) Application Details - K990073

Device Classification Name	Radioimmunoassay, Calcitonin   More FDA Info for this Device
510(K) Number	K990073
Device Name	Radioimmunoassay, Calcitonin
Applicant	KMI DIAGNOSTICS, INC. 373 280TH ST. OSCEOLA, WI 54020 US Other 510(k) Applications for this Company
Contact	GOTTFRIED KELLERMAN Other 510(k) Applications for this Contact
Regulation Number	862.1140   More FDA Info for this Regulation Number
Classification Product Code	JKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/1999
Decision Date	05/11/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review