Atlas FDA

cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH

FDA 510(k) clearance K220134 · decided 2022-09-16

Clearance details

K-number
K220134
Device name
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2022-01-18
Decision date
2022-09-16
Days to decision
241 days
Clearance type
Traditional
Product code
CFR
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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RecordFirmDate
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (K253490)Roche Diagnostics2026-02-12
Glucose2 (K252357)Abbott Ireland2025-10-24
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ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM (K170316)Abbott Laboratories2017-10-19
ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I and ELITROL II (K153644)Elitechgroup2016-09-07
Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose Hexokinase Method (K151487)Diatron U.S., Inc.2016-01-14
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) (K131189)Beckman Coulter, Inc.2014-04-17
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE (K123018)Alfa Wassermann Diagnostic Technologies, Inc.2013-04-23
ADVIA CHEMISTRY GLUH_3 REAGENTS (K120681)Siemens Healthcare Diagnostics, Inc.2012-05-15
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) (K120369)Hitachi Chemical Diagnostics, Inc.2012-05-10
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER (K112377)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2012-03-23
LIASYS 450 (K113131)Ams2012-03-08

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01