FDA 510(k) Application Details - K980120

Device Classification Name	Colorimeter, Photometer, Spectrophotometer For Clinical Use   More FDA Info for this Device
510(K) Number	K980120
Device Name	Colorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant	DIGENE CORP. 9000 VIRGINIA MANOR RD., BELTSVILLE, MD 20705 US Other 510(k) Applications for this Company
Contact	CONSTANCE A FINCH Other 510(k) Applications for this Contact
Regulation Number	862.2300   More FDA Info for this Regulation Number
Classification Product Code	JJQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/1998
Decision Date	02/06/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review