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A-Kem, Inc.

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K884224	TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS	CIG	1988-12-15	View
510(k)	K884226	AMYLASE REAGENT KIT FOR ASTRA SYSTEMS	CJA	1988-12-09	View
510(k)	K884225	TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS	CEK	1988-12-09	View
510(k)	K884227	CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM	JIX	1988-12-09	View
510(k)	K882586	A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM	CIC	1988-08-08	View
510(k)	K882587	A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM	CIX	1988-08-08	View
510(k)	K873131	CREATININE REAGENT KIT	CGX	1987-10-23	View
510(k)	K873127	CHLORIDE REAGENT KIT	JFS	1987-10-23	View
510(k)	K873128	GLUCOSE REAGENT KIT	CGA	1987-10-23	View
510(k)	K873129	CARBON DIOXIDE REAGENT KIT	JFL	1987-10-23	View
510(k)	K873126	SODIUM/POTASSIUM REAGENT KIT	JGS	1987-10-23	View
510(k)	K873130	WASH SOLUTION KIT	JJE	1987-10-23	View
510(k)	K873132	BUN REAGENT KIT	LFP	1987-10-23	View

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