Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFICATION TO ABUSCREEN ONLINE BARBITURATES, MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES, MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
296
Total
296
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roche Diagnostic Systems, Inc. Chemistry ✕
118 devices
Cleared
Oct 09, 1998
ONTRAK TESTCUP AND TESTSTIK CONTROLS
Chemistry
14d
Cleared
Oct 01, 1998
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
Chemistry
50d
Cleared
Aug 26, 1998
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE...
Chemistry
86d
Cleared
Jun 05, 1998
COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)
Chemistry
80d
Cleared
May 21, 1998
COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA...
Chemistry
156d
Cleared
Dec 18, 1997
COBAS INTEGRA HDL-CHOLESTEROL DIRECT
Chemistry
107d
Cleared
Nov 21, 1997
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
Chemistry
74d
Cleared
Oct 01, 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000...
Chemistry
57d
Cleared
Aug 12, 1997
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
Chemistry
57d
Cleared
Aug 06, 1997
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
Chemistry
16d
Cleared
Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
Chemistry
12d
Cleared
Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
Chemistry
24d
Looking for a specific device from Roche Diagnostic Systems, Inc.? Search by device name or K-number.
Search all Roche Diagnostic... devices