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FDA 510(k) Applications Submitted by JEFFREY FLEISHMAN
FDA 510(k) Number
Submission Date
Device Name
Applicant
K970100
01/10/1997
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
SIMPLICITY DIAGNOSTICS, INC.
K060463
02/22/2006
HEMA SCREEN SPECIFIC IFOBT
IMMUNOSTICS, INC.
K061234
05/02/2006
GLUCOPLUS BLOOD GLUCOSE MONITORING SYSTEM
GLUCOPLUS INC
K031490
05/12/2003
RUBELLACOL
IMMUNOSTICS, INC.
K041728
06/25/2004
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
IMMUNOSTICS, INC.
K032985
09/24/2003
GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
HMD BIOMEDICAL, INC.
K023279
10/01/2002
GLUCOLEADER VALUE
HMD BIOMEDICAL, INC.
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