Atlas FDA

TOTAL CO2

FDA 510(k) clearance K951221 · decided 1996-02-15

Clearance details

K-number
K951221
Device name
TOTAL CO2
Applicant
Randox Laboratories, Ltd.
Decision
Substantially Equivalent
Date received
1995-03-20
Decision date
1996-02-15
Days to decision
332 days
Clearance type
Traditional
Product code
KHS
Device class
2
Regulation number
862.1160
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Antrim, N. Ireland, IR
Third-party review
No
Expedited review
No

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Similar devices under this product code

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RecordFirmDate
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S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) (K140248)Hitachi Chemical Diagnostics, Inc.2014-03-11
AU BICARBONATE REAGENT (K131546)Beckman Coulter Ireland, Inc.2013-10-09
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.