Atlas FDA

CO2

FDA 510(k) clearance K981840 · decided 1998-06-08

Clearance details

K-number
K981840
Device name
CO2
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1998-05-26
Decision date
1998-06-08
Days to decision
13 days
Clearance type
Traditional
Product code
KHS
Device class
2
Regulation number
862.1160
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Irving, TX, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

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ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT (K123953)Alfa Wassermann Diagnostic Technologies, Inc.2013-05-02
VITROS CHEMISTRY PRODUCTS ECO2 SLIDES (K120765)Ortho-Clinical Diagnostics, Inc.2012-10-24
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT (K113435)Alfa Wassermann2012-07-02
ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS (K111960)Elitechgroup2011-11-18
EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 (K100060)Vital Diagnostics (Manufacturing) Ptyltd2010-12-15
ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 (K100289)Siemens Healthcare Diagnostics2010-05-10
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; (K093611)Ortho-Clinical Diagnostics, Inc.2010-04-15
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 (K091153)Beckman Coulter, Inc.2009-07-13

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