510(k) K073634
- Device
- MULTIGENT CREATININE (ENZYMATIC) ASSAY
- Applicant
- SENTINEL CH. SpA
- 510(k) number
- K073634
- Product code
- JFY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-06-19
- Date received
- 2007-12-26
- Regulation
- 862.1225
- Classification name
- Enzymatic Method, 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
- FABIO ROTA
- Address
- Via Robert Koch 2 Milan IT 20152 20152
FDA Registration Numbers#
- 3013660430
- 8020316
- 3006198300
- 2431530
- 9610633
- 9710094
- 2030861
- 3010564249
- 1181121
- 2050012
- 3005333358
- 2432235
- 1319809
- 3012963943
- 3015921024
- 1217183
- 1832216
- 2250051
- 1649661
- 8040374
- 3006479639
- 3002809144
- 3006621318
- 1036362
- 3030446844
- 9613069
- 2517506
- 3007662974
- 1827821
- 3002637618
- 3004493545
- 9615507
- 3002642396
- 2050010
- 3010891909
- 2032900
- 3037000637
- 2531491
- 3003917514
- 9681753
- 2085064
- 3008058135
- 1616487
- 9610126
- 2027969
- 3012421607
- 3009448641
- 1220972
- 1319681
- 2030633
- 3021841051
- 3000308930
- 3000148879
- 3004192065
Source Documents#
Other 510(k) Records For Product Code JFY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252619 | QSCHECK UISACR | Qstag, Inc. | 2026-02-20 |
| K212223 | Atellica CH Enzymatic Creatinine_3 (ECre3) | Siemens Healthcare Diagnostics, Inc. | 2021-11-24 |
| K193649 | Yumizen C1200 Creatinine PAP | HORIBA ABX SAS | 2021-05-10 |
| K182384 | ACR LAB Urine Analysis Test System | Healthy.Io, Ltd. | 2019-07-26 |
| K183555 | GEM Premier ChemSTAT | Instrumentation Laboratory CO | 2019-02-16 |
| K182038 | URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer | Yd Diagnostics Corporation | 2018-12-10 |
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System | Ortho-Clinical Diagnostics, Inc. | 2018-10-30 |
| K161527 | Teco Creatinine Enzymatic Reagent Kit | Teco Diagnostics, Inc. | 2017-07-21 |
| K152835 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-03-07 |
| K142391 | Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) | ACON Laboratories, Inc. | 2014-12-22 |
| K132399 | ELITECH CLINICAL SYSTEMS CREATININE PAP SL, ELICAL 2, ELITROL I AND ELITROL II, URINE CONTROL BI-LEVEL | Elitechgroup | 2014-01-03 |
| K103376 | ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL | Seppim S.A.S. | 2011-11-18 |
| K110137 | ABX PENTRA ENZYMATIC CREATININE CP, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, ABX PENTRA P CONTROL, AND ABX PENTRA URIN | HORIBA ABX SAS | 2011-08-10 |
| K093458 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | 2009-12-04 |
| K091742 | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | Beckman Coulter, Inc. | 2009-08-14 |
Legacy Summary#
summary
FDA Review#
Decision Summary