510(k) K123953
- Device
- ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
- Applicant
- ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
- 510(k) number
- K123953
- Product code
- KHS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-05-02
- Date received
- 2012-12-21
- Regulation
- 862.1160
- Classification name
- Enzymatic, Carbon-dioxide
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HYMAN KATZ PH.D.
- Address
- 4 Henderson Dr. West Caldwell NJ US 07006 07006
FDA Registration Numbers#
- 3013660430
- 8020316
- 3006198300
- 2431530
- 3003795116
- 2030861
- 1181121
- 9680746
- 3005333358
- 2432235
- 9610529
- 1319809
- 2250051
- 1217183
- 1832216
- 1181055
- 1036362
- 2517506
- 2247288
- 3007662974
- 1827821
- 1717966
- 3004493545
- 2939693
- 3016438761
- 3003593973
- 3010825766
- 2032900
- 3037000637
- 2085064
- 1616487
- 9610126
- 1220972
- 1319681
- 3000148879
Source Documents#
Other 510(k) Records For Product Code KHS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170200 | Carbon Dioxide Reagent Set | Teco Diagnostics, Inc. | 2017-06-01 |
| K152085 | Liquid CO2-2 (LCO2-2) | Randox Laboratories, Ltd. | 2016-02-24 |
| K140248 | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | Hitachi Chemical Diagnostics, Inc. | 2014-03-11 |
| K131546 | AU BICARBONATE REAGENT | Beckman Coulter Ireland, Inc. | 2013-10-09 |
| K120765 | VITROS CHEMISTRY PRODUCTS ECO2 SLIDES | Ortho-Clinical Diagnostics, Inc. | 2012-10-24 |
| K113435 | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT | Alfa Wassermann | 2012-07-02 |
| K111960 | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS | Elitechgroup | 2011-11-18 |
| K100060 | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 | Vital Diagnostics (Manufacturing) Ptyltd | 2010-12-15 |
| K100289 | ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, MODEL REF 07987100, 07506781 | Siemens Healthcare Diagnostics | 2010-05-10 |
| K093611 | VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; | Ortho-Clinical Diagnostics, Inc. | 2010-04-15 |
| K091153 | SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 | Beckman Coulter, Inc. | 2009-07-13 |
| K073223 | S-TEST C02 | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 |
| K071340 | CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL | Thermofisher Scientific OY | 2007-10-05 |
| K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | Pointe Scientific, Inc., | 2007-04-30 |
| K060619 | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A | Diazyme Laboratories | 2006-07-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary