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."
265–288 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Oct 15, 1985
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
K854009 · DJP
Roche Diagnostic Systems, Inc.
Toxicology · 15d
Cleared Aug 07, 1985
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
K853010 · KLR
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jul 12, 1985
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473 · JGS
Roche Diagnostic Systems, Inc.
Chemistry · 31d
Cleared Jul 09, 1985
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
K852320 · LAR
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Jun 25, 1985
COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS
K852319 · LAN
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jun 25, 1985
COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS
K852318 · LFT
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jun 25, 1985
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
K852317 · KLQ
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared May 10, 1985
COBAS CALIBRATOR SERUM
K850859 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared May 02, 1985
COBAS MIRA
K851172 · JJF
Roche Diagnostic Systems, Inc.
Chemistry · 41d
Cleared Apr 22, 1985
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
K851250 · JSG
Roche Diagnostic Systems, Inc.
Microbiology · 26d
Cleared Apr 22, 1985
SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC
K851249 · JSJ
Roche Diagnostic Systems, Inc.
Microbiology · 26d
Cleared Apr 03, 1985
COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C
K851032 · KXT
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Mar 25, 1985
COBAS FP REAGENTS FOR QUINIDINE
K850808 · LBZ
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Mar 22, 1985
COBAS FP REAGENTS FOR CARBAMAZEPINE
K850807 · KLT
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Mar 14, 1985
ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
K850334 · CHJ
Roche Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Feb 27, 1985
ROCHE STANDARDS FOR CHLORIDE & CO2
K850396 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Feb 01, 1985
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
K843828 · LFW
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 01, 1985
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
K843827 · LCQ
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 01, 1985
COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL
K843826 · LGS
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 01, 1985
COBAS REAGENTS PHENOBARBITAL & PHENOBAR
K843825 · LGQ
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Feb 01, 1985
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR
K843824 · LGR
Roche Diagnostic Systems, Inc.
Toxicology · 126d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR CO2
K844987 · KHS
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Jan 18, 1985
ROCHE REAGENTS REAGENT FOR URIC ACID
K844986 · CDO
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Nov 27, 1984
COBAS FLUORESCENCE POLARIZATION MODULE
K843914 · JJG
Roche Diagnostic Systems, Inc.
Toxicology · 54d