FDA 510(k) Application Details - K972867

Device Classification Name	Aniline   More FDA Info for this Device
510(K) Number	K972867
Device Name	Aniline
Applicant	ROCKET MEDICAL PLC FACTORIES 3 & 4, WEAR INDUSTRIAL ESTATE WASHINGTON, TYNE & WEAR NE37 1NE GB Other 510(k) Applications for this Company
Contact	L TODD Other 510(k) Applications for this Contact
Regulation Number	864.1850   More FDA Info for this Regulation Number
Classification Product Code	ICX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/1997
Decision Date	10/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review