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."
193–216 of 296
Search insights Median review: 66d Cleared: 100% Top manufacturer: Roche Diagnostic Systems, Inc. Lead specialty: Toxicology
Cleared Feb 16, 1990
COBAS READY AST REAGENT
K896238 · CIS
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY ALT REAGENT
K896237 · CKD
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Feb 16, 1990
COBAS READY STAT PROFILE REAGENT STRIP
K896234 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Feb 16, 1990
COBAS READY LIVER PROFILE REAGENT STRIP
K896233 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY TRIGLYCERIDE REAGENT
K896231 · CDT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY TOTAL PROTEIN REAGENT
K896230 · CEK
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY PROFILE 1 REAGENT STRIP
K896229 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY CARDIO PROFILE REAGENT STRIP
K896228 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY URIC ACID REAGENT
K896227 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Jan 26, 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
K895906 · LCM
Roche Diagnostic Systems, Inc.
Toxicology · 112d
Cleared Dec 19, 1989
COBAS READY
K896007 · JJQ
Roche Diagnostic Systems, Inc.
Chemistry · 67d
Cleared Dec 01, 1989
ISOSCREEN-CK CONFIRMATORY KIT
K895870 · JHY
Roche Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Oct 16, 1989
COBAS READY GLUCOSE REAGENT
K895526 · CGA
Roche Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Sep 05, 1989
ROCHE REAGENT FOR URIC ACID
K894101 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 31, 1989
ROCHO ISOMUNE - LD
K894081 · CFE
Roche Diagnostic Systems, Inc.
Chemistry · 84d
Cleared Aug 28, 1989
ABUSCREEN POSITIVE REFERENCE CONTROLS
K894464 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Aug 21, 1989
ABUSCREEN TRI-LEVEL REFERENCE CONTROLS
K894463 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 32d
Cleared Aug 15, 1989
ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE
K894465 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 26d
Cleared Aug 15, 1989
COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS
K891581 · LEG
Roche Diagnostic Systems, Inc.
Toxicology · 148d
Cleared Aug 11, 1989
ROCHE REAGENT FOR TRIGLYCERIDES
K893973 · CDT
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE
K893860 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE
K893859 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC
K893858 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Aug 03, 1989
ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE
K893857 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 70d