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Immunology

891 FDA 510(k) clearances · PMA advisory committee

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RecordFirmDate
CLINICAL ASSAYS (TM) GAMMADAB(R) [ 125 I ] (P790032/S002)Incstar Corp.1991-03-28
CA 125 ANTIBODY RIA (P850009/S004)Centocor, Inc.1991-03-28
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S006)Beckman Coulter, Inc.1990-11-05
ABBOTT COMMANDER(R) PPC AFP-EIA (P820060/S005)Abbott Laboratories1990-08-21
ENZYMUN-TEST{R} AFP (P860044/S001)Boehringer Mannheim Corp.1990-08-03
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S005)Beckman Coulter, Inc.1990-07-10
TANDEM-R(R) CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY (P840019/S009)Hybritech, Inc.1990-04-17
CA 125 ANTIBODY RIA (P850009/S002)Centocor, Inc.1990-02-13
ABBOTT CEA-EIA (P830066/S008)Abbott Laboratories1990-01-10
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S008)Hybritech, Inc.1989-12-13
ABBOTT CEA-EIA (P830066/S007)Abbott Laboratories1989-12-13
CELLFREE INTERLEUKIN-2RECEPTOR ASSAY KIT (P880040)Pierce Biotechnology, Inc.1989-10-06
AMERSHAM AFP (P780006/S003)Ortho Clinical Diagnostics1989-09-26
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S007)Hybritech, Inc.1989-09-06
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S003)Beckman Coulter, Inc.1989-08-21
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S004)Beckman Coulter, Inc.1989-08-10
ABBOTT AFP-EIA DIAGNOSTIC KIT FOR NTDS (P820060/S004)Abbott Laboratories1989-05-09
CEA-ROCHE(R) EIA (P840027/S005)Roche Diagnostics GmbH1989-05-01
CEA-ROCHE(R) EIA (P840027/S006)Roche Diagnostics GmbH1989-05-01
CEA-ROCHE(R) EIA (P840027/S004)Roche Diagnostics GmbH1988-11-29
CEA-ROCHE(R) EIA (P840027/S003)Roche Diagnostics GmbH1988-07-07
TANDEM(R)-E AFP (P840035/S007)Beckman Coulter, Inc.1988-06-03
TANDEM(R)-E AFP (P840035/S003)Beckman Coulter, Inc.1988-04-29
QUANTITOPE 125I AFP KIT AND CONTROL SERUM (P800025/S004)Bio-Rad Laboratories, Inc.1988-04-21
ABBOTT CEA-EIA (P830066/S006)Abbott Laboratories1988-03-28
ABBOTT CEA-EIA ONE-STEP (P830066/S004)Abbott Laboratories1987-11-02
TANDEM(R)-E AFP (P840035/S006)Beckman Coulter, Inc.1987-08-05
CA 125 ANTIBODY RIA (P850009/S001)Centocor, Inc.1987-07-28
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S001)Beckman Coulter, Inc.1987-07-23
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048/S002)Beckman Coulter, Inc.1987-07-10
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S006)Hybritech, Inc.1987-04-30
ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER (P820060/S003)Abbott Laboratories1987-03-09
CEA-ROCHE(R) EIA (P840027/S002)Roche Diagnostics GmbH1987-02-19
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S005)Hybritech, Inc.1986-11-05
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S004)Hybritech, Inc.1986-09-23
CEA-ROCHE(R) EIA (P840027/S001)Roche Diagnostics GmbH1986-09-08
TANDEM(R)-E AFP (P840035/S004)Beckman Coulter, Inc.1986-09-02
GAMMA DAB (125I) AFP RIA KIT (P790032/S001)Incstar Corp.1986-08-22
ABBOTT CEA-EIA KIT (P830066/S003)Abbott Laboratories1986-07-07
ABBOTT CEA-EIA KIT (P830066/S002)Abbott Laboratories1986-07-07
GAMMA DAB (125I) AFP RIA KIT (P790032)Incstar Corp.1986-04-30
ENCORE AFP (P840035/S002)Beckman Coulter, Inc.1986-04-08
AMERSHAM AFP (P780006/S002)Ortho Clinical Diagnostics1986-03-17
TANDEM(R)-E AFP (P840035/S001)Beckman Coulter, Inc.1986-03-06
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S003)Hybritech, Inc.1986-03-06
TANDEM-R PSA IMMUNORADIOMETRIC ASSAY (P850048)Beckman Coulter, Inc.1986-02-25
QUANTITOPE 125I AFP KIT AND CONTROL SERUM (P800025/S003)Bio-Rad Laboratories, Inc.1985-07-17
CEA-ROCHE(R) EIA (P840027)Roche Diagnostics GmbH1985-05-13
ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER (P820060/S002)Abbott Laboratories1985-05-07
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S002)Hybritech, Inc.1985-05-03
ABBOTT AFP (P780005/S001)Abbott Laboratories1985-04-24
TANDEM(R)-R CARCINOEMBRYONIC ANTIGEN ASSAY (P840019/S001)Hybritech, Inc.1985-03-25
AFP MID-PREGNANCY REFERENCE PREPARATION (P820077)Centers for Disease Control and Prevention1984-11-30
CEA-RIA MONOCLONAL (P830066/S001)Abbott Laboratories1984-08-21
ABBOTT AFP (P780005)Abbott Laboratories1984-06-25
AMERSHAM AFP (P780006)Ortho Clinical Diagnostics1984-06-07
AFP RIA KIT (P760001/S001)Alere, Inc.1984-03-01
AFP/OB(TM) RIA KIT (P800025/S001)Bio-Rad Laboratories, Inc.1984-02-22
QUANTITOPE 125I AFP KIT AND CONTROL SERUM (P800025)Bio-Rad Laboratories, Inc.1984-01-13
AFP RIA KIT (P760001)Alere, Inc.1984-01-13
CEA-ROCHE TEST KIT (P800063/S004)Hoffmann-La Roche, Inc.1983-10-18
ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER (P820060/S001)Abbott Laboratories1983-08-31
ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER (P820060)Abbott Laboratories1983-06-21
CEA-ROCHE TEST KIT (P800063/S003)Hoffmann-La Roche, Inc.1982-10-21
CEA-ROCHE TEST KIT (P800063/S002)Hoffmann-La Roche, Inc.1982-09-16
ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA (P800005/S004)Abbott Laboratories1982-03-29
CEA-ROCHE TEST KIT (P800063/S001)Hoffmann-La Roche, Inc.1982-03-03
ABBOTT CEA-EIA TEST KIT (P800056/S003)Abbott Laboratories1982-03-03
ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA (P800005/S003)Abbott Laboratories1981-08-11
CEA--RIA DIXGNOSTIC TEST KIT (P800056/S001)Abbott Laboratories1981-03-11
CEA-RIA DIAGNOSTIC TEST KIT (P800005/S001)Abbott Laboratories1981-03-06
CEA-EIA DIAGNOSTIC TEST KIT (P800056/S002)Abbott Laboratories1981-03-06
ANTI-CARCINOEMBRYONIC ANTIGEN (GOAT) CEA RIA (P800005/S002)Abbott Laboratories1981-03-06
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Every clearance here is in the API, with alerts when new ones post.