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Clinical Chemistry

1,179 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
GUARDIAN RT CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S011)Medtronic Minimed2005-07-18
GLUCOWATCH G2 BIOGRAPHER (P990026/S022)Animas Corp.2004-06-22
GLUCOWATCH G2 BIOGRAPHER (P990026/S021)Animas Corp.2004-02-25
GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS) (P980022/S010)Medtronic Minimed2004-01-07
GLUCOWATCH G2 BIOGRAPHER: MODIFIED GLUCOWATCH G2 BIOGRAPHER & AUTOSENSOR (P990026/S018)Animas Corp.2003-11-20
GLUCOWATCH G2 BIOGRAPHER (P990026/S019)Animas Corp.2003-08-28
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S020)Animas Corp.2003-08-20
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S017)Animas Corp.2003-06-17
GLUCOWATCH G2 BIOGRAPHER (P990026/S016)Animas Corp.2002-12-31
GLUCOWATCH G2 BIOGRAPHER (P990026/S015)Animas Corp.2002-09-23
CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S008)Medtronic Minimed2002-09-05
GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S008)Animas Corp.2002-08-26
GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S014)Animas Corp.2002-08-23
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S013)Animas Corp.2002-07-25
MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S009)Medtronic Minimed2002-06-25
GLUCOWATCH 2 BIOGRAPHER (P990026/S011)Animas Corp.2002-03-21
MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S007)Medtronic Minimed2002-02-20
CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S012)Animas Corp.2002-02-04
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S009)Animas Corp.2001-11-30
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S010)Animas Corp.2001-11-30
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S007)Animas Corp.2001-10-25
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S006)Animas Corp.2001-09-04
GLUCOWATCH(R) AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S005)Animas Corp.2001-08-28
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S004)Animas Corp.2001-08-03
GLUCOWATCH (R) AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S002)Animas Corp.2001-05-22
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026/S001)Animas Corp.2001-05-03
GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER (P990026)Animas Corp.2001-03-22
RAPID FFN FOR THE TLI SYSTEM (P920048/S003)Hologic, Inc.2001-03-09
CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S006)Medtronic Minimed2001-01-09
MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S001)Medtronic Minimed2000-08-09
CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022/S003)Medtronic Minimed2000-03-10
ER-EIA MONOCLONAL (P850029/S002)Abbott Laboratories1999-09-22
PGR-EIA MONOCLONAL (P900013/S002)Abbott Laboratories1999-09-22
SALEST SYSTEM (P970032/S001)Hologic, Inc.1999-08-26
CONTINUOUS GLUCOSE MONITORING SYSTEM (P980022)Medtronic Minimed1999-06-15
ADEZA FETAL FIBRONECTIN EIK (P920048/S002)Hologic, Inc.1998-08-14
SALEST TM SYSTEM (P970032)Hologic, Inc.1998-04-29
PERIOGARD PERIODONTAL TISSUE MONITOR (P960031/S001)Xytronyx, Inc.1997-09-30
PERIOGARD PERIODONTAL TISSUE MONITOR (P960031)Xytronyx, Inc.1997-06-23
ADEZA FETAL FIBRONECTIN EIK (P920048/S001)Hologic, Inc.1997-01-08
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S002)Bio-Rad1996-03-01
IMMUNOCYTOCHEMICAL ASSAY TO DETECT PROGESTERONE (P920006)Abbott Laboratories1995-09-26
ABBOTT ER-EIA MONOCLONAL DIAG. KIT (P850029/S001)Abbott Laboratories1995-07-12
ABBOTT PGR-EIA MONOCLONAL (P900013/S001)Abbott Laboratories1995-07-07
AWARE TEST SYSTEM (P900042)American Drug Screens, Inc.1994-01-18
FLUORO-CEP (R) PROGESTERONE (P900025/S001)Zeus Scientific, Inc.1992-04-21
FLUORO-CEP{R} ESTROGEN ASSAY REAGENT (P860015/S001)Zeus Technologies1992-04-21
FLUORO-CEP (R) PROGESTERONE (P900025/S002)Zeus Scientific, Inc.1992-04-17
FLUORO-CEP{R} ESTROGEN ASSAY REAGENT (P860015/S002)Zeus Technologies1992-04-17
SANDIMMUNE(R) RADIOIMMUNOASSAY KIT (P850086/S001)Sandoz Pharmaceuticals Corp.1991-12-17
PERIOCHECK TM ENZYME ACTIVITY TEST KIT (P870059/S001)Actech Advanced Clinical Technologies, Inc.1991-10-16
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052/S008)Dupont Legal1991-08-06
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032/S001)Bio-Rad1991-03-14
FLUORO-CEP (R) PROGESTERONE (P900025)Zeus Scientific, Inc.1990-09-26
ABBOTT PGR-EIA MONOCLONAL (P900013)Abbott Laboratories1990-09-06
PERIOCHECK TM ENZYME ACTIVITY TEST KIT (P870059)Actech Advanced Clinical Technologies, Inc.1990-08-14
BIO-RAD CYCLOSPORINE BY HPLC TEST (P880032)Bio-Rad1989-07-24
ABBOTT ER-EIA MONOCLONAL DIAG. KIT (P850029)Abbott Laboratories1988-10-17
ABBOTT ER-ICA MONOCLONAL (P880026)Abbott Laboratories1988-09-30
FLUORO-CEP{R} ESTROGEN ASSAY REAGENT (P860015)Zeus Technologies1988-02-29
RIANEN 3H (P800061/S010)Dupont Legal1986-01-16
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052/S007)Dupont Legal1985-07-23
RIANEN 3H (P800061/S009)Dupont Legal1985-07-23
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052/S006)Dupont Legal1985-03-26
RIANEN 3H (P800061/S007)Dupont Legal1985-03-26
RIANEN 3H (P800061/S008)Dupont Legal1985-03-26
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052/S005)Dupont Legal1985-03-26
RIANEN 3H (P800061/S006)Dupont Legal1984-04-24
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052/S001)Dupont Legal1984-02-08
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052/S003)Dupont Legal1984-02-08
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052/S004)Dupont Legal1984-02-08
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052/S002)Dupont Legal1984-02-08
RIANEN(TM) (3H) PROGESTIN RECEPTOR ASSAY KIT (P820052)Dupont Legal1983-08-31
RIANEN 3H (P800061/S005)Dupont Legal1983-01-24
RIANEN 3H (P800061/S003)Dupont Legal1982-12-22
RIANEN 3H (P800061/S004)Dupont Legal1982-12-22
RIANEN 3H (P800061/S002)Dupont Legal1982-05-21
RIANEN I125 (P800061/S001)Dupont Legal1981-06-02
RIANEN 3H (P800061)Dupont Legal1981-06-01
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Every clearance here is in the API, with alerts when new ones post.