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Chembio Diagnostic Systems, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K011550	HCG STAT PAK ULTRA-FAST	JHI	2001-08-14	View
510(k)	K011551	SURE CHECK PREGNANCY TEST	LCX	2001-08-14	View
510(k)	K010244	SURE CHECK OVULATION PREDICTOR	CEP	2001-05-02	View
510(k)	K981913	PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY	LSR	1999-02-12	View
510(k)	K961965	SURE CHECK PREGNANCY TEST	LCX	1996-06-24	View
510(k)	K923925	HCG STAT-PAK	JHI	1992-12-24	View

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