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."
49–72 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Jan 25, 1996
ROCHE COBAS INTEGRA REAGENT CASSETTES
K954992 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Dec 21, 1995
ROCHE CONTROL SERUM P
K954656 · JJY
Roche Diagnostic Systems, Inc.
Immunology · 72d
Cleared Dec 21, 1995
ROCHE CONTROL SERUM N
K954655 · JJY
Roche Diagnostic Systems, Inc.
Immunology · 72d
Cleared Dec 13, 1995
ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL
K954799 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 56d
Cleared Oct 30, 1995
COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID
K953224 · LEG
Roche Diagnostic Systems, Inc.
Toxicology · 139d
Cleared Oct 25, 1995
ROCHE REAGENT FOR BUN
K954000 · CDQ
Roche Diagnostic Systems, Inc.
Chemistry · 61d
Cleared Oct 13, 1995
ROCHE COBAS MICROS HEMATOLOGY ANALYZER
K953448 · GKZ
Roche Diagnostic Systems, Inc.
Hematology · 88d
Cleared Sep 20, 1995
ABUSCREEN ONLINE DRUG FREE URINE
K953845 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 35d
Cleared Sep 20, 1995
ABUSCREEN ONLINE CONTROLS
K953739 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 44d
Cleared Sep 20, 1995
ROCHE CALIBRATOR SERUM
K942706 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 469d
Cleared Sep 15, 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
K952282 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 122d
Cleared Sep 12, 1995
ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN
K953528 · LEH
Roche Diagnostic Systems, Inc.
Toxicology · 47d
Cleared Sep 08, 1995
ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES
K951595 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 155d
Cleared Jul 31, 1995
COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, &...
K952555 · MOJ
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Jun 01, 1995
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS...
K951319 · DOE
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Apr 21, 1995
COBAS CORE FREE T3 EIA
K942376 · CEC
Roche Diagnostic Systems, Inc.
Chemistry · 338d
Cleared Apr 05, 1995
ROCHE ABUSCREEN ONLINE FOR METHAQUALONE
K945187 · KXS
Roche Diagnostic Systems, Inc.
Toxicology · 163d
Cleared Mar 09, 1995
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523 · LCQ
Roche Diagnostic Systems, Inc.
Toxicology · 119d
Cleared Feb 07, 1995
ROCHE-TDM ONLEIN(TM) CONTROLS
K946119 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Jan 25, 1995
ABUSCREEN ONLINE(R) CALIBRATORS
K946000 · DKJ
Roche Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jan 25, 1995
ABUSCREEN ONTRAK POSITIVE CONTROL
K943999 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 187d
Cleared Dec 09, 1994
ABUSCREEN ONLINE PROPOXPHENE
K945195 · JXN
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Dec 09, 1994
ABUSCREEN ONLINE CONTROLS
K945194 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 46d
Cleared Dec 02, 1994
ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC
K944231 · DIO
Roche Diagnostic Systems, Inc.
Chemistry · 93d