FDA 510(k) Applications Submitted by CAROL L KRIEGER

FDA 510(k) Number Submission Date Device Name Applicant
K912754 06/21/1991 ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE ROCHE DIAGNOSTIC SYSTEMS, INC.
K924245 08/24/1992 ROCHE REAGENT FOR ALT ROCHE DIAGNOSTIC SYSTEMS, INC.
K944231 08/31/1994 ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC ROCHE DIAGNOSTIC SYSTEMS, INC.
K904049 09/04/1990 ROCHE COBAS READY RENAL PROFILE REAGENT STRIP ROCHE DIAGNOSTIC SYSTEMS, INC.
K930305 01/21/1993 COBAS CORE PROLACTIN EIA ROCHE DIAGNOSTIC SYSTEMS, INC.
K910085 01/08/1991 ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K910086 01/08/1991 ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K910087 01/08/1991 ABUSCREEN ONLINE OPIATES CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K930269 01/19/1993 COBAS-FP TDM CONTROLS ROCHE DIAGNOSTIC SYSTEMS, INC.
K930304 01/21/1993 COBAS CORE FSH EIA ROCHE DIAGNOSTIC SYSTEMS, INC.
K930306 01/21/1993 COBAS CORE LH EIA ROCHE DIAGNOSTIC SYSTEMS, INC.
K910278 01/23/1991 ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML) ROCHE DIAGNOSTIC SYSTEMS, INC.
K920402 01/31/1992 ROCHE COBAS MIRA PLUS ROCHE DIAGNOSTIC SYSTEMS, INC.
K910551 02/07/1991 ROCHE REAGENT FOR APOLIPOPROTEIN A-1 ROCHE DIAGNOSTIC SYSTEMS, INC.
K910552 02/07/1991 ROCHE REAGENT FOR APOLIPOPROTEIN B ROCHE DIAGNOSTIC SYSTEMS, INC.
K910553 02/07/1991 ROCHE APOLIPOPROTEIN STANDARD ROCHE DIAGNOSTIC SYSTEMS, INC.
K930844 02/18/1993 ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE ROCHE DIAGNOSTIC SYSTEMS, INC.
K930845 02/18/1993 ROCHE ABUSCREEN ONTRAK FOR METHADONE ROCHE DIAGNOSTIC SYSTEMS, INC.
K930889 02/22/1993 ROCHE CARDIOTROL-CK ROCHE DIAGNOSTIC SYSTEMS, INC.
K930890 02/22/1993 COBAS(R) CORE IGE TOTAL EIA ROCHE DIAGNOSTIC SYSTEMS, INC.
K930928 02/23/1993 ROCHE ABUSCREEN ONLINE FOR METHADONE ROCHE DIAGNOSTIC SYSTEMS, INC.
K920829 02/24/1992 COBAS CORE FERRITIN EIA ROCHE DIAGNOSTIC SYSTEMS, INC.
K920935 02/28/1992 ABUSCREEN ONLINE FOR PHENCYCLIDINE ROCHE DIAGNOSTIC SYSTEMS, INC.
K931124 03/04/1993 ABUSCREEN ONLINE(R) CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K931125 03/04/1993 ABUSCREEN ONLINE CONTROL ROCHE DIAGNOSTIC SYSTEMS, INC.
K921180 03/10/1992 COBAS CORE IMMUNOCHEMISTRY SYSTEM ROCHE DIAGNOSTIC SYSTEMS, INC.
K951319 03/23/1995 ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION ROCHE DIAGNOSTIC SYSTEMS, INC.
K941440 03/24/1994 COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K941573 03/31/1994 ROCHE REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC.
K941712 04/06/1994 COBAS-FP REAGENTS AND CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K951595 04/06/1995 ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES ROCHE DIAGNOSTIC SYSTEMS, INC.
K941837 04/13/1994 ROCHE REAGENT FOR CREATININE ROCHE DIAGNOSTIC SYSTEMS, INC.
K921998 04/23/1992 ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED ROCHE DIAGNOSTIC SYSTEMS, INC.
K911838 04/25/1991 ROCHE REAGENT FOR C02 ROCHE DIAGNOSTIC SYSTEMS, INC.
K942048 04/28/1994 ROCHE AMMONIA (VARIOUS) ROCHE DIAGNOSTIC SYSTEMS, INC.
K922043 05/01/1992 ROCHE CALIBRATOR SERUM ROCHE DIAGNOSTIC SYSTEMS, INC.
K942114 05/03/1994 ROCHE TDM CALIBRATION VERIFICATION TEST SET ROCHE DIAGNOSTIC SYSTEMS, INC.
K912048 05/09/1991 ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K922762 05/19/1992 ROCHE REAGENT FOR URIC ACID--MODIFICATION ROCHE DIAGNOSTIC SYSTEMS, INC.
K952337 05/19/1995 ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P ROCHE DIAGNOSTIC SYSTEMS, INC.
K922588 06/01/1992 ROCHE ENTEROTUBE II ROCHE DIAGNOSTIC SYSTEMS, INC.
K922811 06/10/1992 ROCHE COBAS FUTURA GLUCOSE ROCHE DIAGNOSTIC SYSTEMS, INC.
K902560 06/11/1990 ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC.
K902561 06/11/1990 ROCHE COBAS READY CREATININE REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC.
K912574 06/12/1991 ABUSCREEN ONLINE FOR THC (50 AND 100) ROCHE DIAGNOSTIC SYSTEMS, INC.
K912615 06/13/1991 ROCHE COBAS ARGOS 5 DIFF ROCHE DIAGNOSTIC SYSTEMS, INC.
K942847 06/16/1994 COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR ROCHE DIAGNOSTIC SYSTEMS, INC.
K912755 06/21/1991 ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE ROCHE DIAGNOSTIC SYSTEMS, INC.
K912756 06/21/1991 ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE ROCHE DIAGNOSTIC SYSTEMS, INC.
K912757 06/21/1991 ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS ROCHE DIAGNOSTIC SYSTEMS, INC.
K912758 06/21/1991 ABUSCREEN ONLINE FOR AMPHETAMINES ROCHE DIAGNOSTIC SYSTEMS, INC.
K923340 06/25/1992 ROCHE ABUSCREEN ONLINNE CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K902935 07/03/1990 ROCHE COBAS READY HDL CHOLESTEROL REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC.
K923313 07/07/1992 ROCHE OXI/FERM II ROCHE DIAGNOSTIC SYSTEMS, INC.
K913107 07/12/1991 ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ ROCHE DIAGNOSTIC SYSTEMS, INC.
K913124 07/15/1991 ROCHE REAGENT FOR AMMONIA ROCHE DIAGNOSTIC SYSTEMS, INC.
K913125 07/15/1991 ROCHE REAGENT FOR ETHANOL ROCHE DIAGNOSTIC SYSTEMS, INC.
K913335 07/23/1991 ABUSCREEN(R) ONLINE(TM) CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K913336 07/23/1991 ABUSCREEN(R) ONLINE(TM) CONTROLS ROCHE DIAGNOSTIC SYSTEMS, INC.
K903304 07/24/1990 ROCHE COBAS READY GGT REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC.
K903309 07/24/1990 ROCHE COBAS READY AMYLASE REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC.
K913414 07/25/1991 ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT ROCHE DIAGNOSTIC SYSTEMS, INC.
K924113 08/13/1992 ABUSCREEN ONLINE FOR COCAINE METABOLITE ROCHE DIAGNOSTIC SYSTEMS, INC.
K913722 08/16/1991 ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE ROCHE DIAGNOSTIC SYSTEMS, INC.
K924244 08/24/1992 ROCHE REAGENT FOR AST ROCHE DIAGNOSTIC SYSTEMS, INC.
K924246 08/24/1992 ROCHE REAGENT FOR GGT ROCHE DIAGNOSTIC SYSTEMS, INC.
K913911 08/30/1991 ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET ROCHE DIAGNOSTIC SYSTEMS, INC.
K925003 10/02/1992 COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K914468 10/07/1991 ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES ROCHE DIAGNOSTIC SYSTEMS, INC.
K914509 10/09/1991 ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES ROCHE DIAGNOSTIC SYSTEMS, INC.
K935055 10/20/1993 ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) ROCHE DIAGNOSTIC SYSTEMS, INC.
K935042 10/21/1993 ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC.
K914750 10/22/1991 ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR ROCHE DIAGNOSTIC SYSTEMS, INC.
K914806 10/24/1991 ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL ROCHE DIAGNOSTIC SYSTEMS, INC.
K945187 10/24/1994 ROCHE ABUSCREEN ONLINE FOR METHAQUALONE ROCHE DIAGNOSTIC SYSTEMS, INC.
K945523 11/10/1994 COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K935550 11/17/1993 ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK ROCHE DIAGNOSTIC SYSTEMS, INC.
K915516 12/09/1991 ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL ROCHE DIAGNOSTIC SYSTEMS, INC.
K946119 12/15/1994 ROCHE-TDM ONLEIN(TM) CONTROLS ROCHE DIAGNOSTIC SYSTEMS, INC.
K926441 12/23/1992 ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI ROCHE DIAGNOSTIC SYSTEMS, INC.
K926443 12/23/1992 COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K936130 12/23/1993 COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K936131 12/23/1993 COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K905730 12/24/1990 ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) ROCHE DIAGNOSTIC SYSTEMS, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact