Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

479 results for "Roche Diagnostics"
25–48 of 479
Cleared Oct 12, 2022
Elecsys CMV IgG
K220911 · LFZ
Roche Diagnostics
Microbiology · 197d
Cleared Sep 16, 2022
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2,...
K220134 · CFR
Roche Diagnostics
Chemistry · 241d
Cleared Sep 15, 2022
Elecsys AFP
K220176 · LOJ
Roche Diagnostics
Immunology · 237d
Cleared Jun 10, 2022
Elecsys AMH
K203757 · PQO
Roche Diagnostics
Chemistry · 534d
Cleared May 06, 2022
Elecsys Testosterone II
K211685 · CDZ
Roche Diagnostics
Chemistry · 338d
Cleared Mar 31, 2022
Elecsys proBNP II, Elecsys proBNP II STAT
K210546 · NBC
Roche Diagnostics
Chemistry · 399d
Cleared Sep 21, 2021
Elecsys Troponin T Gen 5
K201441 · MMI
Roche Diagnostics
Chemistry · 477d
Cleared Sep 01, 2021
Elecsys Vitamin D total III
K210901 · MRG
Roche Diagnostics
Chemistry · 159d
Cleared Aug 18, 2021
Elecsys HCG STAT
K203227 · DHA
Roche Diagnostics
Chemistry · 289d
Cleared Jul 20, 2021
Elecsys Syphilis
K211302 · LIP
Roche Diagnostics
Microbiology · 82d
Cleared Nov 06, 2020
cobas u 701 microscopy analyzer
K200811 · LKM
Roche Diagnostics
Hematology · 224d
Cleared Mar 26, 2020
Tina-quant Hemoglobin A1cDx Gen.3
K193053 · PDJ
Roche Diagnostics Operations (Rdo)
Chemistry · 146d
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