FDA 510(k) Applications Submitted by ROCHE DIAGNOSTIC SYSTEMS, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K964355 11/01/1996 ONTRAK TESTCUP 5 (MODIFICATION) ROCHE DIAGNOSTIC SYSTEMS, INC.
K963292 08/21/1996 COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS ROCHE DIAGNOSTIC SYSTEMS, INC.
K952337 05/19/1995 ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P ROCHE DIAGNOSTIC SYSTEMS, INC.
K980996 03/17/1998 COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) ROCHE DIAGNOSTIC SYSTEMS, INC.
K971902 05/23/1997 ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT ROCHE DIAGNOSTIC SYSTEMS, INC.
K972214 06/12/1997 ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) ROCHE DIAGNOSTIC SYSTEMS, INC.
K972721 07/21/1997 ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P ROCHE DIAGNOSTIC SYSTEMS, INC.
K972891 08/05/1997 ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION ROCHE DIAGNOSTIC SYSTEMS, INC.
K973075 08/18/1997 ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON ROCHE DIAGNOSTIC SYSTEMS, INC.
K973369 09/08/1997 ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) ROCHE DIAGNOSTIC SYSTEMS, INC.
K974695 12/16/1997 COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) ROCHE DIAGNOSTIC SYSTEMS, INC.
K974840 12/24/1997 ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL ROCHE DIAGNOSTIC SYSTEMS, INC.
K961436 04/15/1996 ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) ROCHE DIAGNOSTIC SYSTEMS, INC.
K961620 04/26/1996 ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 ROCHE DIAGNOSTIC SYSTEMS, INC.
K961674 05/01/1996 ROCHE UNIMATE FRUCTOSAMINE REAGENT ROCHE DIAGNOSTIC SYSTEMS, INC.
K961726 05/03/1996 ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 ROCHE DIAGNOSTIC SYSTEMS, INC.
K961824 05/10/1996 COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN ROCHE DIAGNOSTIC SYSTEMS, INC.
K962280 06/13/1996 ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR ROCHE DIAGNOSTIC SYSTEMS, INC.
K972250 06/16/1997 ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS ROCHE DIAGNOSTIC SYSTEMS, INC.
K962411 06/21/1996 ONTRAK TESTCUP AMPHETAMINES ROCHE DIAGNOSTIC SYSTEMS, INC.
K982848 08/12/1998 COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT ROCHE DIAGNOSTIC SYSTEMS, INC.
K953847 08/16/1995 ROCHE REAGENT FOR GLUCOSE ROCHE DIAGNOSTIC SYSTEMS, INC.
K973284 09/02/1997 COBAS INTEGRA HDL-CHOLESTEROL DIRECT ROCHE DIAGNOSTIC SYSTEMS, INC.
K983174 09/10/1998 ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES ROCHE DIAGNOSTIC SYSTEMS, INC.
K983387 09/25/1998 ONTRAK TESTCUP AND TESTSTIK CONTROLS ROCHE DIAGNOSTIC SYSTEMS, INC.
K983555 10/13/1998 ABUSCREEN ONLINE BENZ 200 CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K983556 10/13/1998 ABUSCREEN ONLINE BENZ 300 CALIBRATORS ROCHE DIAGNOSTIC SYSTEMS, INC.
K954992 10/31/1995 ROCHE COBAS INTEGRA REAGENT CASSETTES ROCHE DIAGNOSTIC SYSTEMS, INC.
K981584 05/04/1998 ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) ROCHE DIAGNOSTIC SYSTEMS, INC.
K981585 05/04/1998 ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) ROCHE DIAGNOSTIC SYSTEMS, INC.
K981897 06/01/1998 ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE ROCHE DIAGNOSTIC SYSTEMS, INC.
K962165 06/04/1996 COBAS-FP TDM CALIBRATION VERIFICATION TEST SET ROCHE DIAGNOSTIC SYSTEMS, INC.
K962231 06/10/1996 COBAS CORE IMMUNOCHEMISTRY SYSTEM ROCHE DIAGNOSTIC SYSTEMS, INC.
K982087 06/15/1998 ROCHE CRP T CONTROL N ROCHE DIAGNOSTIC SYSTEMS, INC.
K982382 07/08/1998 COBAS INTEGRA REAGENT CASSETTES ROCHE DIAGNOSTIC SYSTEMS, INC.
K982551 07/22/1998 ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN ROCHE DIAGNOSTIC SYSTEMS, INC.
K963627 09/11/1996 (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE ROCHE DIAGNOSTIC SYSTEMS, INC.
K983388 09/25/1998 ONTRAK TESTCUP-ER ROCHE DIAGNOSTIC SYSTEMS, INC.
K983697 10/21/1998 MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE ROCHE DIAGNOSTIC SYSTEMS, INC.
K983698 10/21/1998 MODIFICATION TO ABUSCREEN ONLINE BARBITURATES ROCHE DIAGNOSTIC SYSTEMS, INC.
K983699 10/21/1998 MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES ROCHE DIAGNOSTIC SYSTEMS, INC.
K983700 10/21/1998 MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE ROCHE DIAGNOSTIC SYSTEMS, INC.
K983701 10/21/1998 MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS ROCHE DIAGNOSTIC SYSTEMS, INC.
K983702 10/21/1998 MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES ROCHE DIAGNOSTIC SYSTEMS, INC.
K983703 10/21/1998 MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE ROCHE DIAGNOSTIC SYSTEMS, INC.
K983704 10/21/1998 MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE ROCHE DIAGNOSTIC SYSTEMS, INC.
K964422 11/05/1996 ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL ROCHE DIAGNOSTIC SYSTEMS, INC.
K964457 11/06/1996 ROCHE COBAS IBTEGRA REAGENT CASSETTES ROCHE DIAGNOSTIC SYSTEMS, INC.
K964670 11/21/1996 ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN ROCHE DIAGNOSTIC SYSTEMS, INC.


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