510(k) K132638
- Device
- DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE
- Applicant
- Siemens Healthcare Diagnostics Inc.
- 510(k) number
- K132638
- Product code
- CGX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-01-27
- Date received
- 2013-08-23
- Regulation
- 862.1225
- Classification name
- Alkaline Picrate, Colorimetry, Creatinine
- 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
- LAURA J DUGGAN, PH.D.
- Address
- 500 Gbc Dr., M/S 514, P.O. Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 3005094123
- 3006198300
- 8020316
- 1063851
- 9616671
- 9610633
- 3003795116
- 2030861
- 3003030793
- 1818910
- 1181121
- 9680746
- 2050012
- 3005333358
- 2432235
- 9610529
- 1832216
- 3002809144
- 2517506
- 2247288
- 1827821
- 3011989923
- 3002637618
- 3004493545
- 2939693
- 3016438761
- 3003593973
- 2050010
- 3010825766
- 2085064
- 1616487
- 3004875840
- 9610126
- 1220972
- 3023162659
- 1219029
- 3006716639
- 3000148879
- 3004192065
Source Documents#
Other 510(k) Records For Product Code CGX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252206 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2026-01-09 |
| K251058 | Tru Kidney Health Test Panel; Tru Analyzer | Truvian Health | 2025-11-26 |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | Siemens Healthcare Diagnostics, Inc. | 2024-12-04 |
| K221813 | Nova Allegro UACR Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024-11-19 |
| K210452 | Creatinine2 | Abbott Ireland Diagnostics Division | 2022-03-22 |
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) | Siemens Healthcare Diagnostics, Inc. | 2016-11-15 |
| K133728 | DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics, Inc. | 2014-01-24 |
| K123586 | EASYRA CREATININE REAGENT | Medica Corporation | 2013-05-15 |
| K110530 | ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PENTRA P CONTROL; ABX PENTRA URINE CONTROL | HORIBA ABX SAS | 2012-04-30 |
| K083809 | CREATININE | Abbott Laboratories | 2009-04-07 |
| K072115 | ABX PENTRA CREATININE 120 CP, TOTAL PROTEIN 100 CP, MULTICAL, N AND P CONTROLS, AND URINE CONTROL L/H | Horiba Abx | 2007-11-30 |
| K071277 | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | 2007-06-01 |
| K071280 | SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | Beckman Coulter, Inc. | 2007-06-01 |
| K071283 | SYNCHRON SYSTEMS CREATININE REAGENT | Beckman Coulter, Inc. | 2007-06-01 |
| K061193 | CREATININE | Abbott Laboratories, Inc. | 2006-06-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary