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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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