CDQ — Urease And Glutamic Dehydrogenase, Urea Nitrogen Class II
FDA product code CDQ covers "Urease And Glutamic Dehydrogenase, Urea Nitrogen", a Class II medical device regulated under 21 CFR 862.1770. 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
- CDQ
- Device Class
- Class II
- Regulation Number
- 862.1770
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K203771 | abbott ireland diagnostics division | Urea Nitrogen2 | May 31, 2022 |
| K140690 | shenzhen mindray bio-medical electronics co | BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER | September 2, 2014 |
| K110675 | medica | EASYRA UREA NITROGEN AND CREATININE REAGENTS | April 21, 2011 |
| K073295 | thermofisher scientific | UREA/BUN, SCAL, NORTROL, ABTROL | May 29, 2008 |
| K070146 | horiba abx | ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP | October 12, 2007 |
| K060120 | teco diagnostics | TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM | March 27, 2006 |
| K041051 | hemagen diagnostics | RAICHEM BUN RATE REAGENT (LIQUID) | June 30, 2004 |
| K024182 | precision systems | PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS | March 3, 2003 |
| K021385 | elan diagnostics | ATAC PAK BUN REAGENT | July 12, 2002 |
| K012649 | hemagen diagnostics | RAICHEM BUN RATE REAGENT | October 15, 2001 |
| K012260 | wiener laboratories saic | WIENER LAB. UREA UV CINETICA AA | September 19, 2001 |
| K011596 | jas diagnostic | UREA NITROGEN (BUN) LIQUID REAGENT | July 17, 2001 |
| K002694 | diagnostic chemicals | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 | September 15, 2000 |
| K000958 | elan holdings | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | May 24, 2000 |
| K993925 | wako chemicals usa | WAKO L-TYPE UN TEST | April 3, 2000 |
| K993178 | diagnostic chemicals | UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 | October 18, 1999 |
| K992800 | sigma diagnostics | SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P | September 28, 1999 |
| K990980 | a.p. total care | BUN, MODEL BU 104-01 | May 25, 1999 |
| K982236 | sigma diagnostics | SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT | August 5, 1998 |
| K981918 | abbott laboratories | UREA | July 28, 1998 |