FDA 510(k) Applications Submitted by Chembio Diagnostic Systems, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K010244 01/25/2001 SURE CHECK OVULATION PREDICTOR Chembio Diagnostic Systems, Inc.
K011550 05/18/2001 HCG STAT PAK ULTRA-FAST Chembio Diagnostic Systems, Inc.
K011551 05/18/2001 SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc.
K981913 06/01/1998 PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY Chembio Diagnostic Systems, Inc.
K961965 05/20/1996 SURE CHECK PREGNANCY TEST Chembio Diagnostic Systems, Inc.


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