Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

296 results for "Roche Diagnostic Systems, Inc."
73–96 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Dec 02, 1994
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
K942847 · LAR
Roche Diagnostic Systems, Inc.
Toxicology · 169d
Cleared Oct 31, 1994
ROCHE REAGENT
K941573 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 214d
Cleared Oct 04, 1994
ROCHE AMMONIA (VARIOUS)
K942048 · DKB
Roche Diagnostic Systems, Inc.
Chemistry · 159d
Cleared Sep 02, 1994
ROCHE TDM CALIBRATION VERIFICATION TEST SET
K942114 · DIF
Roche Diagnostic Systems, Inc.
Chemistry · 122d
Cleared Aug 26, 1994
ROCHE REAGENT FOR CREATININE
K941837 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 135d
Cleared Aug 09, 1994
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
K935055 · DOE
Roche Diagnostic Systems, Inc.
Toxicology · 293d
Cleared Jul 06, 1994
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
K941440 · LBZ
Roche Diagnostic Systems, Inc.
Toxicology · 104d
Cleared Jun 13, 1994
COBAS-FP REAGENTS AND CALIBRATORS
K941712 · LGJ
Roche Diagnostic Systems, Inc.
Toxicology · 68d
Cleared Mar 11, 1994
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
K936131 · LGR
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Mar 11, 1994
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
K936130 · LGQ
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Jan 27, 1994
ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE
K930844 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 343d
Cleared Jan 25, 1994
ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT
K935042 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 96d
Cleared Jan 24, 1994
COBAS(R) CORE FT4 EIA
K932607 · CEC
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Jan 24, 1994
COBAS (R) CORE T4 EIA
K932605 · KLI
Roche Diagnostic Systems, Inc.
Chemistry · 241d
Cleared Jan 03, 1994
ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK
K935550 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 47d
Cleared Dec 29, 1993
ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS
K932548 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 217d
Cleared Dec 03, 1993
COBAS(R) CORE T3 EIA
K932608 · CDP
Roche Diagnostic Systems, Inc.
Chemistry · 189d
Cleared Dec 03, 1993
COBAS CORE TSH EIA
K930776 · JLW
Roche Diagnostic Systems, Inc.
Chemistry · 290d
Cleared Sep 24, 1993
ROCHE ABUSCREEN ONLINE FOR METHADONE
K930928 · DJR
Roche Diagnostic Systems, Inc.
Toxicology · 213d
Cleared Sep 21, 1993
COBAS CORE FSH EIA
K930304 · CGJ
Roche Diagnostic Systems, Inc.
Chemistry · 243d
Cleared Sep 15, 1993
ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED
K933052 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Aug 30, 1993
ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF
K933053 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 96d
Cleared Aug 26, 1993
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
K932549 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Aug 19, 1993
COBAS CORE PROLACTIN EIA
K930305 · CFT
Roche Diagnostic Systems, Inc.
Chemistry · 210d