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

491 results for "Roche Diagnostics"
49–72 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
Cleared Mar 09, 2020
Elecsys BRAHMS PCT
K192815 · PRI
Roche Diagnostics
Microbiology · 160d
Cleared Feb 27, 2020
Elecsys Anti-TSHR
K193313 · JZO
Roche Diagnostics
Immunology · 90d
Cleared Feb 21, 2020
Tina-quant C-Reactive Protein IV
K192072 · DCN
Roche Diagnostics Operations (Rdo)
Immunology · 203d
Cleared Aug 16, 2019
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro...
K191899 · CFR
Roche Diagnostics
Chemistry · 31d
Cleared Aug 13, 2019
Elecsys Anti-HAV II
K190428 · LOL
Roche Diagnostics
Microbiology · 172d
Cleared May 07, 2019
cobas u 601 urinalysis test system
K183432 · JIL
Roche Diagnostics
Chemistry · 147d
Cleared Apr 16, 2019
Elecsys TSH
K190773 · JLW
Roche Diagnostics
Chemistry · 21d
Cleared Feb 08, 2019
Ammonia II
K183517 · JIF
Roche Diagnostics Operations (Rdo)
Chemistry · 52d
Cleared Nov 06, 2018
Elecsys Tacrolimus
K173857 · MLM
Roche Diagnostics
Toxicology · 321d
Cleared Nov 05, 2018
Tina-quant Transferrin ver.2 (urine application)
K182095 · DDG
Roche Diagnostics Operations (Rdo)
Immunology · 94d
Cleared Sep 18, 2018
Elecsys FT4 III
K181233 · CEC
Roche Diagnostics
Chemistry · 132d
Cleared Jul 06, 2018
Elecsys BRAHMS PCT
K173927 · PRI
Roche Diagnostics
Microbiology · 192d
Cleared Jun 22, 2018
Elecsys CA 15-3 II
K181492 · MOI
Roche Diagnostics
Immunology · 16d
Cleared Apr 19, 2018
CoaguChek XS Pro System
K180693 · GJS
Roche Diagnostics
Hematology · 34d
Cleared Apr 19, 2018
CoaguChek XS Plus System
K180684 · GJS
Roche Diagnostics
Hematology · 35d
Cleared Mar 02, 2018
cobas m 511 integrated hematology analyzer
K171655 · GKZ
Roche Diagnostics Hematology, Inc.
Hematology · 270d
Cleared Feb 20, 2018
Elecsys CA 15-3 II
K171605 · MOI
Roche Diagnostics
Immunology · 264d
Cleared Dec 25, 2017
CoaguChek Vantus System
K170960 · GJS
Roche Diagnostics
Hematology · 269d
Cleared Jul 28, 2017
cobas HbA1c Test, cobas b 101 system
K163633 · LCP
Roche Diagnostics Operations
Chemistry · 218d
Cleared Jun 23, 2017
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · LGD
Roche Diagnostics
Microbiology · 270d
Cleared May 26, 2017
Creatine Kinase-MB
K162526 · JHW
Roche Diagnostics
Chemistry · 259d
Cleared May 10, 2017
ALP IFCC Gen.2
K171080 · CJE
Roche Diagnostics Operations (Rdo)
Chemistry · 29d
Cleared Apr 26, 2017
CalSet IGF-1
K170938 · JIT
Roche Diagnostics
Chemistry · 27d
Cleared Apr 04, 2017
Beta-CrossLaps CalCheck 5
K170678 · JJX
Roche Diagnostics
Chemistry · 29d