FDA 510(k) Applications Submitted by BRUNI, PH.D

FDA 510(k) Number Submission Date Device Name Applicant
K860221 01/22/1986 ENCORE PROLACTIN REAGENT HYBRITECH, INC.
K870422 02/03/1987 GEN-PROBE BETA-LACTAMASE TEST KIT GEN-PROBE, INC.
K860542 02/12/1986 TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT HYBRITECH, INC.
K860778 03/03/1986 TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT HYBRITECH, INC.
K860984 03/17/1986 TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT HYBRITECH, INC.
K881277 03/18/1988 PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS GEN-PROBE, INC.
K931598 04/01/1993 BIOSITE TRIAGE PANEL FOR DRUGS OF ABUSE(50NG/ML) BIOSITE INCORPORATED
K892216 04/03/1989 GEN-PROBE PACE SYSTEM URINE SCREEN GEN-PROBE, INC.
K871795 05/07/1987 RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. GEN-PROBE, INC.
K871878 05/14/1987 RAPID DIAGNOSTIC SYSTEM FOR CHLAMYDIA TRACHOMATIS GEN-PROBE, INC.
K852385 06/05/1985 HYBRITECH IMMUNOCHEMISTRY ANALYZER HYBRITECH, INC.
K872219 06/12/1987 GEN-PROBE (R) LUMINOMETER - LEADER (TM) GEN-PROBE, INC.
K862956 08/05/1986 ICON READER HYBRITECH, INC.
K863345 08/29/1986 TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY HYBRITECH, INC.
K863858 10/03/1986 TANDEM-M IMMUNOENZYMETRIC ASSAY FOR IGE-- HYBRITECH, INC.
K863859 10/03/1986 TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM HYBRITECH, INC.
K863860 10/03/1986 TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN HYBRITECH, INC.
K863861 10/03/1986 TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONA HYBRITECH, INC.
K874620 11/09/1987 GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE GEN-PROBE, INC.
K874878 11/30/1987 GEN-PROBE(R) PACE(TM) SYSTEM CHLAMYDIA TRACHOMATIS GEN-PROBE, INC.
K864945 12/17/1986 TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY HYBRITECH, INC.
K897078 12/22/1989 ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE GEN-PROBE, INC.
K897079 12/22/1989 ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE GEN-PROBE, INC.
K865057 12/24/1986 TANDEMR ICONR II HCG(SERUM) IMMUNOENZYMETRIC ASSAY HYBRITECH, INC.
K890089 01/10/1989 RAPID DIAG. SYSTEM FOR MYCOBACTERIUM GORDONAE GEN-PROBE, INC.
K862674 07/14/1986 PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM HYBRITECH, INC.
K895583 09/15/1989 ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA. GEN-PROBE, INC.
K863841 10/01/1986 TANDEM OTC HCG PREGNANCY TEST FOR CONSUMER USE HYBRITECH, INC.
K896492 11/13/1989 ACCUPROBE MYCOBACTERIUM GORDONAE CULTURE TEST GEN-PROBE, INC.
K896493 11/13/1989 ACCUPROBE MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST GEN-PROBE, INC.
K896494 11/13/1989 ACCUPROBE MYCOBACTERIUM AVIUM CULTURE TEST GEN-PROBE, INC.
K896859 12/05/1989 ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST GEN-PROBE, INC.
K897077 12/22/1989 ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE GEN-PROBE, INC.


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