510(k) K070146
- Device
- ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
- Applicant
- HORIBA ABX
- 510(k) number
- K070146
- Product code
- CDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-10-12
- Date received
- 2007-01-16
- Regulation
- 862.1770
- Classification name
- Urease And Glutamic Dehydrogenase, Urea Nitrogen
- 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
- PASCAL MACZIOLA
- Address
- Parc Euromedecine Rue Du Caducee Bp7290 Montpellier FR 34184 34184
FDA Registration Numbers#
- 8040374
- 8020316
- 3006716639
- 2030861
- 2517506
- 3016438761
- 3005333358
- 3006198300
- 3013660430
- 3004493545
- 1319436
- 3011989923
- 9680746
- 2085064
- 1616487
- 3010825766
- 2221819
- 1220972
- 3000148879
- 3003593973
- 9610126
- 3003795116
- 1217183
- 1181121
- 1832216
- 3009156722
- 3037000637
- 1827821
- 2431530
- 2050012
- 1063851
- 3007603826
- 9610529
- 2050010
- 3007662974
- 2432235
Source Documents#
Other 510(k) Records For Product Code CDQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203771 | Urea Nitrogen2 | Abbott Ireland Diagnostics Division | 2022-05-31 |
| K140690 | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2014-09-02 |
| K110675 | EASYRA UREA NITROGEN AND CREATININE REAGENTS | Medica Corp. | 2011-04-21 |
| K073295 | UREA/BUN, SCAL, NORTROL, ABTROL | Thermofisher Scientific OY | 2008-05-29 |
| K060120 | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | Teco Diagnostics | 2006-03-27 |
| K041051 | RAICHEM BUN RATE REAGENT (LIQUID) | Hemagen Diagnostics, Inc. | 2004-06-30 |
| K024182 | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS | Precision Systems, Inc. | 2003-03-03 |
| K021385 | ATAC PAK BUN REAGENT | Elan Diagnostics | 2002-07-12 |
| K012649 | RAICHEM BUN RATE REAGENT | Hemagen Diagnostics, Inc. | 2001-10-15 |
| K012260 | WIENER LAB. UREA UV CINETICA AA | Wiener Laboratories Saic | 2001-09-19 |
| K011596 | UREA NITROGEN (BUN) LIQUID REAGENT | Jas Diagnostic, Inc. | 2001-07-17 |
| K002694 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | Diagnostic Chemicals , Ltd. | 2000-09-15 |
| K000958 | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | Elan Holdings, Inc. | 2000-05-24 |
| K993925 | WAKO L-TYPE UN TEST | Wako Chemicals USA, Inc. | 2000-04-03 |
| K993178 | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | Diagnostic Chemicals , Ltd. | 1999-10-18 |
Legacy Summary#
summary
FDA Review#
Decision Summary