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."
25–48 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Nov 21, 1997
ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM)
K973369 · LBR
Roche Diagnostic Systems, Inc.
Chemistry · 74d
Cleared Oct 09, 1997
ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK...
K973075 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 52d
Cleared Oct 01, 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000...
K972891 · DKZ
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Aug 12, 1997
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K972250 · JFJ
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Aug 06, 1997
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
K972721 · JJX
Roche Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Jun 24, 1997
ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN)
K972214 · JJY
Roche Diagnostic Systems, Inc.
Chemistry · 12d
Cleared Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · LBS
Roche Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Feb 04, 1997
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
K964670 · LFW
Roche Diagnostic Systems, Inc.
Toxicology · 75d
Cleared Jan 13, 1997
ROCHE COBAS IBTEGRA REAGENT CASSETTES
K964457 · JQB
Roche Diagnostic Systems, Inc.
Chemistry · 68d
Cleared Dec 13, 1996
ONTRAK TESTCUP 5 (MODIFICATION)
K964355 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 42d
Cleared Nov 25, 1996
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
K964422 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Oct 31, 1996
COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K963292 · CIC
Roche Diagnostic Systems, Inc.
Chemistry · 71d
Cleared Oct 24, 1996
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
K963627 · JGS
Roche Diagnostic Systems, Inc.
Chemistry · 43d
Cleared Oct 07, 1996
ONTRAK TESTCUP AMPHETAMINES
K962411 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 108d
Cleared Sep 27, 1996
ROCHE UNIMATE FRUCTOSAMINE REAGENT
K961674 · LCP
Roche Diagnostic Systems, Inc.
Chemistry · 149d
Cleared Aug 30, 1996
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K962231 · JJE
Roche Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Aug 16, 1996
ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR
K962280 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 64d
Cleared Jul 23, 1996
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
K961824 · DCF
Roche Diagnostic Systems, Inc.
Immunology · 74d
Cleared Jul 11, 1996
ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20
K961726 · DLJ
Roche Diagnostic Systems, Inc.
Toxicology · 69d
Cleared Jun 26, 1996
COBAS-FP TDM CALIBRATION VERIFICATION TEST SET
K962165 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jun 21, 1996
ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)
K961436 · DLB
Roche Diagnostic Systems, Inc.
Toxicology · 67d
Cleared Jun 13, 1996
ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100
K961620 · LAT
Roche Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Feb 13, 1996
ROCHE REAGENT FOR GLUCOSE
K953847 · CFR
Roche Diagnostic Systems, Inc.
Chemistry · 181d
Cleared Feb 09, 1996
ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P
K952337 · LCP
Roche Diagnostic Systems, Inc.
Hematology · 266d