Bun Reagent Astra 4 & 8 Analyzers
FDA 510(k) K802518 · Nobel Scientific Industries, Inc.
510(k) numberK802518
Submission
- Device name
- Bun Reagent Astra 4 & 8 Analyzers
- Applicant
- Nobel Scientific Industries, Inc.
Mchenry, IL, US - Received
- October 15, 1980
- Decision date
- November 12, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDN – Urease, Photometric, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA SlidesCDN · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/14/2019SE |
| K132462 | S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreCDN · Traditional | Hitachi Chemical Diagnostics, Inc. | 10/28/2013SE |
| K123322 | Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK ReagentCDN · Traditional | Alfa Wassermann Diagnostics Technologies, LLC | 05/21/2013SE |
| K113389 | Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentCDN · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 08/10/2012SE |
| K103615 | Ace Urea Nitrogen Reagent, Calcium-Arseazo Reagent, Creatinine Reagent, Inorganic…CDN · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 09/08/2011SE |
| K001885 | Vitros Chemistry Products Bun/Urea Slides and Vitros Chemistry Products Calibrator Kit 1CDN · Special | Ortho-Clinical Diagnostics, Inc. | 07/20/2000SE |
| K972012 | Cholestech Bun/Creatinine Test SystemCDN · Traditional | Cholestech Corp. | 07/24/1997SE |
| K961196 | Ektachem Clinical Chemistry Urea Nitrogen/Urea (Bun/Urea)CDN · Traditional | Johnson & Johnson Clinical Diagnostics, Inc. | 05/15/1996SE |
| K943042 | Bun QvetCDN · Traditional | Prisma Systems | 12/29/1994SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | King Diagnostics, Inc. | 10/13/1992SE |
More from King Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K854717 | Nsi Astra TM Total Protein Reagent Kit, Nsi #7928CEK · Traditional | 01/14/1986SE |
| K854716 | Nsi Astra TM Calcium Reagent Kit Nsi Item # 7909CIC · Traditional | 01/07/1986SE |
| K854718 | Nsi Astra TM Albumin Reagent Kit Nsi Item # 7926CIX · Traditional | 12/19/1985SE |
| K850944 | Nsi Lysing-D Reagent -4000 MLGGK · Traditional | 03/29/1985SE |
| K844782 | Nsi Elt-D Diluting Fluid 4000MLGIF · Traditional | 03/05/1985SE |
| K823283 | Flushing Solution · Traditional | 12/03/1982SE |
| K812866 | Astra Reagent Concentrate SystemCGA · Traditional | 12/17/1981SE |
| K810550 | Silver AnodeJFS · Traditional | 04/08/1981SE |
| K810549 | Thermal Printer PaperJJE · Traditional | 04/08/1981SE |
| K801346 | Nsi Reagent System for Ortho ELT-8 HemaGIF · Traditional | 08/12/1980SE |
Questions and answers
When was Bun Reagent Astra 4 & 8 Analyzers cleared by the FDA?
Bun Reagent Astra 4 & 8 Analyzers (K802518) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 28 days after the submission was received.
What is the product code of K802518?
The FDA product code is CDN – Urease, Photometric, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.