Chembio Diagnostic Systems, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Chembio Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Chembio Diagnostic Systems, Inc. has 6 FDA 510(k) cleared medical devices. Based in Medford, US.
Historical record: 6 cleared submissions from 1992 to 2001. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Chembio Diagnostic Systems, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Chembio Diagnostic Systems, Inc.
6 devices
Cleared
Aug 14, 2001
HCG STAT PAK ULTRA-FAST
Chemistry
88d
Cleared
Aug 14, 2001
SURE CHECK PREGNANCY TEST
Chemistry
88d
Cleared
May 02, 2001
SURE CHECK OVULATION PREDICTOR
Chemistry
97d
Cleared
Feb 12, 1999
PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY
Microbiology
256d
Cleared
Jun 24, 1996
SURE CHECK PREGNANCY TEST
Chemistry
35d
Cleared
Dec 24, 1992
HCG STAT-PAK
Chemistry
141d