Roche Diagnostics - FDA 510(k) Cleared Devices
188
Total
185
Cleared
3
Denied
188 devices
Cleared
Feb 25, 2011
ROCHE FLUDI METHAMPHETAMINE
Toxicology
434d
Cleared
Feb 11, 2011
ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A
Chemistry
402d
Cleared
Feb 11, 2011
ROCHE ORAL FLUID COCAINE
Chemistry
291d
Cleared
Feb 11, 2011
ELECSYS ANTI-TPO CALSET
Immunology
107d
Cleared
Jan 25, 2011
ORAL FLUID PHENCYCLIDINE
Chemistry
397d
Cleared
Jan 20, 2011
ELECYSYS SHBG
Chemistry
114d
Cleared
Jan 07, 2011
ELECSYS DHEA-S CALCHECK 5
Chemistry
49d
Cleared
Dec 23, 2010
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5
Chemistry
52d
Cleared
Dec 06, 2010
PRECICONTROL HBA1C NORM
Chemistry
47d
Cleared
Nov 18, 2010
ELECSYS PTH CALCHECK 5
Chemistry
22d
Cleared
Nov 01, 2010
ELECSYS CA 125 II CALCHECK 5
Immunology
98d
Cleared
Oct 07, 2010
ELECSYS IGE CALCHECK 5
Immunology
59d
Cleared
Oct 05, 2010
ELECSYS CEA CALCHECK 5
Immunology
96d
Cleared
Sep 10, 2010
TINA-QUANT ALBUMIN GEN 2
Chemistry
134d
Cleared
Sep 10, 2010
ELECSYS FERRITIN CALCHECK 5
Chemistry
32d
Cleared
Sep 08, 2010
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS...
Chemistry
105d
Cleared
Sep 01, 2010
PRECICONTROL CLINCHEM MULTI 1 AND 2
Chemistry
44d
Cleared
Aug 31, 2010
ELECSYS DIGOXIN CALCHECK 5
Chemistry
41d
Cleared
Aug 27, 2010
ELECSYS PRECICONTROL MULTIMARKER
Chemistry
28d
Cleared
Jun 22, 2010
ANTI-HAV IGM
Microbiology
181d
Cleared
Jun 22, 2010
TINA-QUANT FERRITIN GEN. 4
Immunology
117d
Cleared
Apr 27, 2010
ELECSYS FOLATE III CALCHECK 5
Chemistry
118d
Cleared
Apr 26, 2010
ELECSYS C-PEPTIDE CALCHECK 5
Chemistry
35d
Cleared
Apr 15, 2010
ELECSYS TSH CALCHECK 5
Chemistry
121d
Cleared
Apr 02, 2010
COBAS U411 TEST SYSTEM
Chemistry
136d
Looking for a specific device from Roche Diagnostics? Search by device name or K-number.
Search all Roche Diagnostics devices