Harleco Diagnostics

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K823147	URIC ACID STANDARD, 8MG/DL #65078	JIS	1982-11-22	View
510(k)	K822852	TRIGLYCERIDE CALIBRATOR	JIT	1982-10-27	View
510(k)	K822323	ULTRACHEM BUN-UV, 65080 & 65081	CDW	1982-09-02	View
510(k)	K821880	ULTRA CHEM ALB	CIX	1982-07-14	View
510(k)	K821877	ULTRAZYME PLUS HBD	JMK	1982-07-14	View
510(k)	K821879	ULTRACHEM T.P.	CEX	1982-07-14	View
510(k)	K821872	ULTRACHEM URIC ACID AIDH	CDO	1982-07-14	View
510(k)	K821882	ULTRAZYME PLUS GPT	CKA	1982-07-14	View
510(k)	K821873	ULTRACHEM T-BILI	CIG	1982-07-14	View
510(k)	K821878	ULTRAZYME PLUS LDH	CFJ	1982-07-14	View
510(k)	K821871	ULTRAZYME PLUS 2GT	JPZ	1982-07-14	View
510(k)	K821881	ULTRACHEM CREA	CGX	1982-07-14	View
510(k)	K821883	ULTRAZYME PLUS CK-I	CGS	1982-07-14	View
510(k)	K821876	ULTRAZYME PLUS GOT	CIT	1982-07-13	View
510(k)	K821874	ULTRACHEM PHOS	CEO	1982-07-13	View
510(k)	K821875	ULTRACHEM TRI-ES	CDT	1982-07-13	View
510(k)	K821870	ULTRAZYME PLUS ALP	CJE	1982-07-13	View
510(k)	K821869	ULTRAZYME PLUS AMYL	JFJ	1982-07-13	View
510(k)	K821868	ULTRACHEM E-GLU	CFR	1982-07-08	View
510(k)	K821867	ULTRACHEM GLUC-DH	LFR	1982-07-06	View