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."
169–192 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Oct 12, 1990
ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
K904049 · JGZ
Roche Diagnostic Systems, Inc.
Chemistry · 38d
Cleared Oct 12, 1990
ROCHE COBAS READY GGT REAGENT
K903304 · JPZ
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Sep 27, 1990
ROCHE COBAS READY HDL CHOLESTEROL REAGENT
K902935 · JHM
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Sep 07, 1990
ROCHE COBAS READY AMYLASE REAGENT
K903309 · JFJ
Roche Diagnostic Systems, Inc.
Chemistry · 45d
Cleared Sep 07, 1990
ROCHE COBAS READY CREATININE REAGENT
K902561 · CGX
Roche Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 17, 1990
COBAS READY CALCIUM REAGENT
K896224 · CIC
Roche Diagnostic Systems, Inc.
Chemistry · 291d
Cleared Aug 09, 1990
ROCHE ISOMUNE- CK
K903025 · JHS
Roche Diagnostic Systems, Inc.
Chemistry · 30d
Cleared Jul 17, 1990
ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT
K902560 · CJE
Roche Diagnostic Systems, Inc.
Chemistry · 36d
Cleared Jun 26, 1990
COBAS READY CALIBRATOR KIT
K897097 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 187d
Cleared Jun 26, 1990
COBAS READY PROFILE 2 REAGENT STRIP
K896225 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 239d
Cleared Jun 12, 1990
ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY
K900718 · LCP
Roche Diagnostic Systems, Inc.
Chemistry · 118d
Cleared May 30, 1990
ROTAG CONTROLS
K900719 · JJX
Roche Diagnostic Systems, Inc.
Chemistry · 105d
Cleared May 23, 1990
ROCHE REAGENT FOR MAGNESIUM
K901758 · JGJ
Roche Diagnostic Systems, Inc.
Chemistry · 35d
Cleared May 02, 1990
COBAS-FP REAGENTS FOR VANCOMYCIN
K901759 · LEH
Roche Diagnostic Systems, Inc.
Chemistry · 14d
Cleared Mar 30, 1990
ROCHE REAGENT FOR LDH
K900121 · CFJ
Roche Diagnostic Systems, Inc.
Chemistry · 80d
Cleared Mar 09, 1990
ABUSCREEN FP FOR METHAMPHETAMINE
K900143 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 57d
Cleared Mar 09, 1990
ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL
K900120 · LBR
Roche Diagnostic Systems, Inc.
Chemistry · 59d
Cleared Mar 09, 1990
ROCHE STANDARDS FOR THE COBAS ISE MODULE
K897071 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 77d
Cleared Feb 27, 1990
COBAS READY BUN REAGENT
K896236 · JGZ
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 27, 1990
COBAS READY ALBUMIN REAGENT
K896235 · CIX
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 27, 1990
COBAS READY TOTAL BILIRUBIN REAGENT
K896232 · CIG
Roche Diagnostic Systems, Inc.
Chemistry · 120d
Cleared Feb 16, 1990
COBAS READY LDH REAGENT
K896241 · CFJ
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY CK REAGENT
K896240 · JHY
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY CHOLESTEROL REAGENT
K896239 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 109d