Search FDA 510(k) Devices

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

479 results for "Roche Diagnostics"
457–479 of 479
Cleared Sep 28, 1999
ELECSYS PARATHYROID HORMONE TEST SYSTEM
K992680 · CEW
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Sep 24, 1999
ELECSYS ESTRADIOL CALSET II
K992981 · JIT
Roche Diagnostics Corp.
Chemistry · 21d
Cleared Jul 22, 1999
COBAS INTEGRA ACETAMINOPHEN
K991598 · LDP
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jul 22, 1999
COBAS INTEGRA AMIKACIN MAB
K991597 · LGJ
Roche Diagnostics Corp.
Toxicology · 73d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · JXM
Roche Diagnostics Corp.
Toxicology · 57d
Cleared Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BARBITURATES
K991440 · DIS
Roche Diagnostics Corp.
Toxicology · 57d
Cleared Apr 15, 1999
ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
K990409 · DMY
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 15, 1999
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
K990399 · DKZ
Roche Diagnostics Corp.
Toxicology · 65d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
K990595 · DFC
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
K990594 · DER
Roche Diagnostics Corp.
Chemistry · 49d
Cleared Apr 13, 1999
ONTRAK TESTCUP-ER M2K
K990418 · DKZ
Roche Diagnostics Corp.
Toxicology · 62d
Cleared Apr 13, 1999
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT...
K983892 · JPA
Roche Diagnostics/Boehringer Mannheim...
Hematology · 161d
Cleared Mar 22, 1999
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
K990460 · JIX
Roche Diagnostics Corp.
Chemistry · 38d
Cleared Feb 26, 1999
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544,...
K990377 · DIF
Roche Diagnostics Corp.
Toxicology · 18d
Cleared Feb 23, 1999
ONTRAK TESTCUP-5 M2K
K990337 · DKZ
Roche Diagnostics Corp.
Toxicology · 20d
Cleared Dec 01, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS...
K983503 · CEO
Boehringer Mannheim Corp.
Chemistry · 56d
Cleared Oct 21, 1998
ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353
K983416 · JGJ
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Aug 25, 1998
CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS...
K981931 · CGN
Roche Diagnostics/Boehringer Mannheim...
Chemistry · 84d
Cleared Jul 07, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN...
K981883 · CIG
Boehringer Mannheim Corp.
Chemistry · 39d
Cleared Jun 15, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
K981632 · CIG
Roche Diagnostics/Boehringer Mannheim...
Chemistry · 38d
Cleared May 01, 1998
ELECSYS AFP
K981282 · LOJ
Roche Diagnostics GmbH
Immunology · 23d
Cleared Apr 24, 1998
ELECSYS CALCHECK FERRITIN
K981281 · JJX
Roche Diagnostics GmbH
Chemistry · 16d
Cleared Apr 23, 1998
ELECSYS CALCHECK CA 125II
K981278 · JJX
Roche Diagnostics GmbH
Chemistry · 15d