Medical Device Manufacturer · US , Indianapolis , IN

Roche Diagnostics Corp.

264 submissions · 263 cleared · Since 1999
264
Total
263
Cleared
1
Denied

Roche Diagnostics Corp. — FDA 510(k) Submissions

Roche Diagnostics Corp. has submitted 264 FDA 510(k) premarket notifications since 1999, of which 263 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Multi-analyte Controls, All Kinds (assayed), System, Test, Blood Glucose, Over The Counter, Calibrator, Secondary, Glucose Dehydrogenase, Glucose . Use the specialty filter in the sidebar to narrow results.

264 devices
1–25 of 264
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · NBW System, Test, Blood... · Chemistry
Mar 2013 56d
ELECSYS CA 19-9 CALCHECK 5
K101365 · JJX Single (specified)... · Immunology
Oct 2010 141d
COBAS 8000 MODULAR SERIES ANALYZER
K100853 · DCF Albumin, Antigen,... · Chemistry
Sep 2010 167d
ACCU-CHEK ULTRFLEX INFUSION SET
K101196 · FPA Set, Administration,... · General Hospital
Aug 2010 120d
AMPHETAMINES II ASSAY
K093664 · DKZ Enzyme Immunoassay,... · Chemistry
Jul 2010 243d
ELECSYS INSULIN CALCHECK 5
K101075 · JJX Single (specified)... · Chemistry
Jun 2010 53d
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · CDZ Radioimmunoassay,... · Chemistry
Apr 2010 171d
ELECSYS TROPONIN T CALCHECK 5
K092848 · JJX Single (specified)... · Chemistry
Mar 2010 184d
COAGUCHEK XS PLUS PST SYSTEM
K092940 · GJS Test, Time, Prothrombin · Hematology
Mar 2010 162d
ELECSYS HCG STAT CALCHECK 5
K093700 · JJX Single (specified)... · Chemistry
Mar 2010 93d
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190
K092649 · NBC Test, Natriuretic Peptide · Chemistry
Feb 2010 160d
AMPHETAMINES II
K083764 · DKZ Enzyme Immunoassay,... · Chemistry
Feb 2010 412d
ELECSYS TOXO IGG CALCHECK 5
K092888 · JJX Single (specified)... · Microbiology
Nov 2009 50d
ELECYS ANTI-CCP CALCHECK
K091601 · JJX Single (specified)... · Chemistry
Sep 2009 114d
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS
K082340 · CGN Acid, Folic,... · Chemistry
Jun 2009 308d
C-REACTIVE PROTEIN (LATEX)
K083444 · DCN System, Test, C-reactive... · Immunology
Mar 2009 117d
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · LFX Enzyme Linked... · Microbiology
Dec 2008 445d
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · JZO System, Test, Thyroid... · Immunology
Jul 2008 196d
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
K080811 · NDY Test, Cystatin C · Chemistry
Jun 2008 88d
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · LGD Enzyme Linked... · Microbiology
Jun 2008 179d
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
K080227 · MRZ Accessories, Pump, Infusion · General Hospital
May 2008 106d
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · JIX Calibrator, Multi-analyte... · Chemistry
May 2008 69d
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · LCP Assay, Glycosylated... · Chemistry
Apr 2008 206d
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
K080183 · DIF Drug Mixture Control... · Chemistry
Mar 2008 60d
COBAS LITHIUM
K063684 · NDW Assay, Porphyrin,... · Toxicology
Mar 2008 465d

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