Company ยท US
Roche Diagnostic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1999. Name variants (Inc, Corp, punctuation) are merged.
296510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 17 |
| DIF | Drug Mixture Control Materials | 14 |
| LAS | Drug Specific Control Materials | 14 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 11 |
| DKB | Calibrators, Drug Mixture | 10 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 9 |
| JIX | Calibrator, Multi-Analyte Mixture | 9 |
| DLJ | Calibrators, Drug Specific | 8 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 7 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 6 |
| DIS | Enzyme Immunoassay, Barbiturate | 6 |
| DJG | Enzyme Immunoassay, Opiates | 5 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 4 |
| KLN | Radioimmunoassay, Cocaine Metabolite | 4 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 4 |
| LAT | Radioimmunoassay, Cannabinoid(S) | 4 |
| LCM | Enzyme Immunoassay, Phencyclidine | 4 |
| LCP | Assay, Glycosylated Hemoglobin | 4 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 3 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 3, 1999 | K983698 | MODIFICATION TO ABUSCREEN ONLINE BARBITURATES Roche Diagnostic Systems, Inc. | DIS |
| Feb 11, 1999 | K983702 | MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES Roche Diagnostic Systems, Inc. | JXM |
| Feb 10, 1999 | K983704 | MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE Roche Diagnostic Systems, Inc. | JCM |
| Dec 15, 1998 | K983556 | ABUSCREEN ONLINE BENZ 300 CALIBRATORS Roche Diagnostic Systems, Inc. | DLJ |
| Dec 15, 1998 | K983555 | ABUSCREEN ONLINE BENZ 200 CALIBRATORS Roche Diagnostic Systems, Inc. | DLJ |
| Dec 11, 1998 | K983703 | MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE Roche Diagnostic Systems, Inc. | DJR |
| Dec 11, 1998 | K983701 | MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS Roche Diagnostic Systems, Inc. | LDJ |
| Dec 11, 1998 | K983700 | MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE Roche Diagnostic Systems, Inc. | JXN |
| Dec 11, 1998 | K983699 | MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES Roche Diagnostic Systems, Inc. | DKZ |
| Dec 11, 1998 | K983697 | MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE Roche Diagnostic Systems, Inc. | DIO |
| Nov 18, 1998 | K983388 | ONTRAK TESTCUP-ER Roche Diagnostic Systems, Inc. | DIO |
| Nov 18, 1998 | K983174 | ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES Roche Diagnostic Systems, Inc. | JXM |
| Oct 9, 1998 | K983387 | ONTRAK TESTCUP AND TESTSTIK CONTROLS Roche Diagnostic Systems, Inc. | DIF |
| Oct 1, 1998 | K982848 | COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT Roche Diagnostic Systems, Inc. | MRR |
| Sep 28, 1998 | K982382 | COBAS INTEGRA REAGENT CASSETTES Roche Diagnostic Systems, Inc. | CFN |
| Aug 26, 1998 | K981897 | ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE Roche Diagnostic Systems, Inc. | CJE |
| Aug 18, 1998 | K982551 | ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN Roche Diagnostic Systems, Inc. | DIS |
| Aug 18, 1998 | K982087 | ROCHE CRP T CONTROL N Roche Diagnostic Systems, Inc. | DCK |
| Jun 5, 1998 | K980996 | COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) Roche Diagnostic Systems, Inc. | KHS |
| May 28, 1998 | K981585 | ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) Roche Diagnostic Systems, Inc. | LDJ |
| May 28, 1998 | K981584 | ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) Roche Diagnostic Systems, Inc. | LDJ |
| May 21, 1998 | K974695 | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) Roche Diagnostic Systems, Inc. | CKB |
| Apr 24, 1998 | K974840 | ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL Roche Diagnostic Systems, Inc. | DJG |
| Dec 18, 1997 | K973284 | COBAS INTEGRA HDL-CHOLESTEROL DIRECT Roche Diagnostic Systems, Inc. | CHH |
| Nov 21, 1997 | K973369 | ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) Roche Diagnostic Systems, Inc. | LBR |
| Oct 9, 1997 | K973075 | ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON Roche Diagnostic Systems, Inc. | DKZ |
| Oct 1, 1997 | K972891 | ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION Roche Diagnostic Systems, Inc. | DKZ |
| Aug 12, 1997 | K972250 | ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS Roche Diagnostic Systems, Inc. | JFJ |
| Aug 6, 1997 | K972721 | ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P Roche Diagnostic Systems, Inc. | JJX |
| Jun 24, 1997 | K972214 | ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) Roche Diagnostic Systems, Inc. | JJY |
| Jun 16, 1997 | K971902 | ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT Roche Diagnostic Systems, Inc. | LBS |
| Feb 4, 1997 | K964670 | ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN Roche Diagnostic Systems, Inc. | LFW |
| Jan 13, 1997 | K964457 | ROCHE COBAS IBTEGRA REAGENT CASSETTES Roche Diagnostic Systems, Inc. | JQB |
| Dec 13, 1996 | K964355 | ONTRAK TESTCUP 5 (MODIFICATION) Roche Diagnostic Systems, Inc. | LCM |
| Nov 25, 1996 | K964422 | ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL Roche Diagnostic Systems, Inc. | DIF |
| Oct 31, 1996 | K963292 | COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS Roche Diagnostic Systems, Inc. | CIC |
| Oct 24, 1996 | K963627 | (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE Roche Diagnostic Systems, Inc. | JGS |
| Oct 7, 1996 | K962411 | ONTRAK TESTCUP AMPHETAMINES Roche Diagnostic Systems, Inc. | DKZ |
| Sep 27, 1996 | K961674 | ROCHE UNIMATE FRUCTOSAMINE REAGENT Roche Diagnostic Systems, Inc. | LCP |
| Aug 30, 1996 | K962231 | COBAS CORE IMMUNOCHEMISTRY SYSTEM Roche Diagnostic Systems, Inc. | JJE |
| Aug 16, 1996 | K962280 | ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR Roche Diagnostic Systems, Inc. | DLJ |
| Jul 23, 1996 | K961824 | COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN Roche Diagnostic Systems, Inc. | DCF |
| Jul 11, 1996 | K961726 | ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 Roche Diagnostic Systems, Inc. | DLJ |
| Jun 26, 1996 | K962165 | COBAS-FP TDM CALIBRATION VERIFICATION TEST SET Roche Diagnostic Systems, Inc. | DIF |
| Jun 21, 1996 | K961436 | ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) Roche Diagnostic Systems, Inc. | DLB |
| Jun 13, 1996 | K961620 | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 Roche Diagnostic Systems, Inc. | LAT |
| Feb 13, 1996 | K953847 | ROCHE REAGENT FOR GLUCOSE Roche Diagnostic Systems, Inc. | CFR |
| Feb 9, 1996 | K952337 | ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P Roche Diagnostic Systems, Inc. | LCP |
| Jan 25, 1996 | K954992 | ROCHE COBAS INTEGRA REAGENT CASSETTES Roche Diagnostic Systems, Inc. | CIT |
| Dec 21, 1995 | K954656 | ROCHE CONTROL SERUM P Roche Diagnostic Systems, Inc. | JJY |
Newest 50 of 296.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||