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Cala Diagnostics

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K944247	CARDIOCHEX CKMB IMMUNOINHIBITION CONTROL	JJT	1994-10-31	View
510(k)	K944246	CARDIOCHEX CKMB MASS MEASUREMENT CONTROL	JJT	1994-10-31	View
510(k)	K944243	CARDIOCHEX	JJT	1994-10-27	View
510(k)	K930874	LD-1 CONTROL-LEVEL 1 & 2	JJX	1993-04-22	View
510(k)	K930873	CKMB ISOENZYME CONTROL-LEVEL 1,2.3	JJT	1993-04-13	View
510(k)	K930875	CKMB CONTROL - LEVEL 1,2,3	JJT	1993-04-13	View
510(k)	K926015	CKMB CONTROL FOR MASS MEASUREMENT-LEVELS 1,2,3	JJX	1992-12-28	View
510(k)	K915503	FIBRINOGEN FDP CONTROL	DAP	1992-01-30	View
510(k)	K912827	SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3	DKC	1991-08-12	View
510(k)	K912826	WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2	DKC	1991-07-26	View
510(k)	K864456	CYCLOSPORIN A (WHOLE BLOOD) CONTROL - LEVELS 1,2,3	LAS	1987-05-06	View
510(k)	K850907	CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/	JJT	1985-06-25	View

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