Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

479 results for "Roche Diagnostics"
361–384 of 479
Cleared Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND...
K020831 · GJS
Roche Diagnostics Corp.
Hematology · 224d
Cleared Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
K021218 · JFT
Roche Diagnostics Corp.
Chemistry · 145d
Cleared Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · JHY
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672 · JZO
Roche Diagnostics Corp.
Immunology · 157d
Cleared Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
K022171 · NBW
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jul 16, 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · DJR
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 16, 2002
ONLINE DAT II METHADONE II
K021505 · DJR
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 12, 2002
ROCHE ONLINE GENTAMICIN
K020704 · LCD
Roche Diagnostics Corp.
Toxicology · 130d
Cleared Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827 · NBW
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
K021513 · NBW
Roche Diagnostics Corp.
Chemistry · 33d
Cleared Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021448 · NBW
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
K020740 · KLS
Roche Diagnostics Corp.
Toxicology · 41d
Cleared Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
K014139 · CGA
Roche Diagnostics Corp.
Chemistry · 94d
Cleared Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
K020369 · JJX
Roche Diagnostics Corp.
Immunology · 30d
Cleared Jan 08, 2002
ROCHE ACETAMINOPHEN
K013757 · LDP
Roche Diagnostics Corp.
Toxicology · 56d
Cleared Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
K013482 · DJG
Roche Diagnostics Corp.
Toxicology · 63d
Cleared Dec 05, 2001
ACCU-CHEK ACTIVE TEST SYSTEM
K012324 · NBW
Roche Diagnostics Corp.
Chemistry · 135d
Cleared Nov 30, 2001
INFLUENZA A/B RAPID TEST, CAT NO 2158 663
K011684 · PSZ
Roche Diagnostics Corp.
Microbiology · 184d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · CZW
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359 · DBI
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
K013249 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013206 · DFC
Roche Diagnostics Corp.
Chemistry · 52d
Cleared Nov 15, 2001
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
K013278 · DEL
Roche Diagnostics Corp.
Chemistry · 45d
Cleared Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
K013207 · DFC
Roche Diagnostics Corp.
Chemistry · 49d