KHS — Enzymatic, Carbon-Dioxide Class II
FDA product code KHS covers "Enzymatic, Carbon-Dioxide", a Class II medical device regulated under 21 CFR 862.1160. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KHS
- Device Class
- Class II
- Regulation Number
- 862.1160
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K170200 | teco diagnostics | Carbon Dioxide Reagent Set | June 1, 2017 |
| K152085 | randox laboratories | Liquid CO2-2 (LCO2-2) | February 24, 2016 |
| K140248 | hitachi chemical diagnostics | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | March 11, 2014 |
| K131546 | beckman coulter ireland | AU BICARBONATE REAGENT | October 9, 2013 |
| K123953 | alfa wassermann diagnostic technologies | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REA | May 2, 2013 |
| K120765 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS ECO2 SLIDES | October 24, 2012 |
| K113435 | alfa wassermann | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILI | July 2, 2012 |
| K111960 | elitechgroup | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE | November 18, 2011 |
| K100060 | vital diagnostics (manufacturing) ptyltd | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77 | December 15, 2010 |
| K100289 | siemens healthcare diagnostics | ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, | May 10, 2010 |
| K093611 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATO | April 15, 2010 |
| K091153 | beckman coulter | SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 | July 13, 2009 |
| K073223 | alfa wassermann diagnostic technologies | S-TEST C02 | June 26, 2008 |
| K071340 | thermofisher scientific | CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL | October 5, 2007 |
| K070251 | pointe scientific, inc | CARBON DIOXIDE LIQUID STABLE REAGENT | April 30, 2007 |
| K060619 | diazyme laboratories | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A | July 21, 2006 |
| K061238 | dade behring | DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGEN | May 25, 2006 |
| K060295 | abbott laboratories | CARBON DIOXIDE | May 4, 2006 |
| K042362 | diagnostic chemicals | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299- | December 27, 2004 |
| K032377 | roche diagnostics | ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID | August 21, 2003 |