FDA 510(k) Application Details - K000471

Device Classification Name	Radioimmunoassay, Parathyroid Hormone   More FDA Info for this Device
510(K) Number	K000471
Device Name	Radioimmunoassay, Parathyroid Hormone
Applicant	FUTURE DIAGNOSTICS B.V. 4079 MT. BARNARD SAN DIEGO, CA 92111 US Other 510(k) Applications for this Company
Contact	DAVE D SMITH Other 510(k) Applications for this Contact
Regulation Number	862.1545   More FDA Info for this Regulation Number
Classification Product Code	CEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/2000
Decision Date	04/11/2000
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