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Pathology

1,195 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
PREPSTAIN SYSTEM (P970018/S007)Bd Diagnostic Systems2004-05-28
DAKOCYTOMATION EGFR PHARMDX (P030044)Agilent Technologies, Inc.2004-02-12
THINPREP 2000 SYSTEM (P950039/S011)Hologic, Inc.2004-02-09
PREPSTAIN SYSTEM (P970018/S005)Bd Diagnostic Systems2003-10-27
DAKOCYTOMATION HERCEP TEST (P980018/S002)Agilent Technologies Singapore (International) Pte , Ltd.2003-06-11
THINPREP (R) IMAGING SYSTEM (P020002)Hologic, Inc.2003-06-06
PREPSTAIN (TM) SYSTEM (P970018/S006)Bd Diagnostic Systems2003-05-02
THINPEP 2000 SYSTEM AND THINPREP 3000 PROCESSOR: PRESERVCYT SOLUTION, ALTERNATIVE TRANSPORT MEDIUM FOR ROCHE DIAGNOSTIC (P950039/S010)Hologic, Inc.2003-03-27
PRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM (P950039/S009)Hologic, Inc.2003-02-05
DAKO HERCEPTEST (P980018/S001)Agilent Technologies Singapore (International) Pte , Ltd.2002-12-12
PATHWAY HER 2 (CLONE CB11) (P990081/S001)Ventana Medical Systems, Inc.2002-11-27
PREPSTAIN SYSTEM (P970018/S004)Bd Diagnostic Systems2002-10-01
THINPREP PROCESSOR (MODEL TP-2000) (P950039/S008)Hologic, Inc.2002-06-05
PATHVYSION HER-2 DNA PROBE KIT (P980024/S001)Abbott Molecular, Inc.2001-12-31
FOCALPOINT SYSTEMCREENING SYSTEM (P950009/S005)Bd Diagnostics2001-11-02
PREPSTAIN SYSTEM (P970018/S003)Bd Diagnostic Systems2001-11-02
AUTOPAP PRIMARY SCREENING SYSTEM (P950009/S004)Bd Diagnostics2001-10-05
THINPREP(R) 2000 SYSTEM (P950039/S007)Hologic, Inc.2001-08-06
AUTOCYTE PREP SYSTEM (P970018/S002)Bd Diagnostic Systems2001-05-25
PATHWAY ANTI-HCR-2/NCU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY (P990081)Ventana Medical Systems, Inc.2000-11-28
AUTOCYTE PREP SYSTEM (P970018/S001)Bd Diagnostic Systems2000-08-29
INFORM HER-2/NEU (P940004/S001)Ventana Medical Systems, Inc.2000-08-01
THINPREP 3000 PROCESSOR (P950039/S006)Hologic, Inc.2000-05-25
BD PREPSTAIN SYSTEM (P970018)Bd Diagnostic Systems1999-06-17
AUTOPAP SYSTEM (P950009/S003)Bd Diagnostics1999-01-19
PATHVYSION HER-2 DNA PROBE KIT (P980024)Abbott Molecular, Inc.1998-12-11
DAKO HERCEPTEST (P980018)Agilent Technologies Singapore (International) Pte , Ltd.1998-09-25
AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM (P950009/S002)Bd Diagnostics1998-05-05
ONCOR(R) AMPLITECT(TM) HER/NEU(ERBB2)GENE AMPLIFI (P940004)Ventana Medical Systems, Inc.1997-12-30
THINPREP 2000 SYSTEM (P950039/S004)Hologic, Inc.1997-10-08
PAPNET (R) TESTING SYSTEM (P940029/S003)Bd Diagnostics1997-06-25
THINPREP(R) PROCESSOR (P950039/S003)Hologic, Inc.1997-04-08
THINPREP(R) 2000 SYSTEM (P950039/S002)Hologic, Inc.1997-02-25
THINPREP(R) PROCESSOR (P950039/S005)Hologic, Inc.1996-11-06
PAPNET (R) TESTING SYSTEM (P940029/S001)Bd Diagnostics1996-10-21
PAPNET (R) TESTING SYSTEM (P940029/S002)Bd Diagnostics1996-09-30
THINPREP(R) PROCESSOR (P950039/S001)Hologic, Inc.1996-08-22
THINPREP(R) PROCESSOR, MODEL TP 2000 (P950039)Hologic, Inc.1996-05-20
AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM (P950009/S001)Bd Diagnostics1996-04-25
PAPNET (R) TESTING SYSTEM (P940029)Bd Diagnostics1995-11-08
AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM (P950009)Bd Diagnostics1995-09-29
OSI TRANSPROBE-1 (P880045)Osi Pharmaceuticals, Inc.1989-10-03
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