FDA 510(k) Application Details - K953680

Device Classification Name	Nitroprusside, Ketones (Urinary, Non-Quant.)   More FDA Info for this Device
510(K) Number	K953680
Device Name	Nitroprusside, Ketones (Urinary, Non-Quant.)
Applicant	POLYMER TECHNOLOGY INTL. 1871 N.W. GILMAN BLVD. ISSAQUAH, WA 98027 US Other 510(k) Applications for this Company
Contact	ESTELA FIGUEROA Other 510(k) Applications for this Contact
Regulation Number	862.1435   More FDA Info for this Regulation Number
Classification Product Code	JIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/1995
Decision Date	06/12/1996
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