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Siemens Healthcare Diagnostics, Inc.

122 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
ACS 180/ADVIA CENTAUR AFP IMMUNOASSAY (P930036/S003)Siemens Healthcare Diagnostics, Inc.2005-10-07
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S002)Siemens Healthcare Diagnostics, Inc.2005-03-25
BAYER VERSANT HCV RNA 3.0 ASSAY (BDNA) (P020022/S001)Siemens Healthcare Diagnostics, Inc.2004-12-14
IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA (P930027/S006)Siemens Healthcare Diagnostics, Inc.2003-12-31
IMMULITE 2500 AFP, MODEL L5KAP (P010007/S002)Siemens Healthcare Diagnostics, Inc.2003-12-31
BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA) (P020022)Siemens Healthcare Diagnostics, Inc.2003-03-28
IMMULITE/IMMULITE 1000 PSA & 1000 THIRD GENERATION PSA (P930027/S005)Siemens Healthcare Diagnostics, Inc.2003-02-28
IMMULITE AFP AND IMMULITE 2000 AFP (P010007/S001)Siemens Healthcare Diagnostics, Inc.2003-02-24
ACS:180/ADVIA CENTAUR AFP IMMUNOASSAY (P930036/S002)Siemens Healthcare Diagnostics, Inc.2002-02-12
IMMULITE/IMMULITE 1000 AFP AND IMMULITE 2000/IMMULITE 2500 AFP (P010007)Siemens Healthcare Diagnostics, Inc.2001-11-09
IMMULITE(R)PSA, IMMULITE(R) THIRD GENERATION PSA, IMMULITE(R) 2000 (P930027/S004)Siemens Healthcare Diagnostics, Inc.2001-06-19
ACS: CENTAUR AFP IMMUNOASSAY (P930036/S001)Siemens Healthcare Diagnostics, Inc.1998-07-15
IMMULITE PSA CATALOG # LKPS1,5) (P930027/S003)Siemens Healthcare Diagnostics, Inc.1998-05-08
IMMULITE(R) THIRD GENERATION PSA (P930027/S001)Siemens Healthcare Diagnostics, Inc.1996-07-11
ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS (P930036)Siemens Healthcare Diagnostics, Inc.1995-09-29
IMMULITE SYSTEMS PSA & THIRD GENERATION PSA REAGENTS (P930027)Siemens Healthcare Diagnostics, Inc.1995-09-15
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