Atlas FDA

GLUCOSE

FDA 510(k) clearance K060383 · decided 2006-05-05

Clearance details

K-number
K060383
Device name
GLUCOSE
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
2006-02-14
Decision date
2006-05-05
Days to decision
80 days
Clearance type
Traditional
Product code
CFR
Device class
2
Regulation number
862.1345
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Abbott Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (K253490)Roche Diagnostics2026-02-12
Glucose2 (K252357)Abbott Ireland2025-10-24
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (K220134)Roche Diagnostics2022-09-16
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions (K191899)Roche Diagnostics2019-08-16
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30