Nsi Astra TM Albumin Reagent Kit Nsi Item # 7926
FDA 510(k) K854718 · Nobel Scientific Industries, Inc.
510(k) numberK854718
Submission
- Device name
- Nsi Astra TM Albumin Reagent Kit Nsi Item # 7926
- Applicant
- Nobel Scientific Industries, Inc.
Alexandria, VA, US - Received
- November 22, 1985
- Decision date
- December 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIX
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|---|---|---|---|
| K251157 | Core MetabolicCIX · Traditional | Truvian Health | 01/09/2026SE |
| K203248 | Albumin BCG2CIX · Traditional | Abbott Ireland Diagnostics Division | 11/23/2021SE |
| K200898 | Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon…CIX · Traditional | Medicon Hellas S.A | 09/21/2021SE |
| K191316 | VITROS XT Chemistry Products ALB-TP SlidesCIX · Traditional | Ortho-Clinical Diagnostics, Inc. | 06/07/2019SE |
| K170901 | Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, BA400CIX · Traditional | Biosystems S.A. | 04/13/2018SE |
| K131488 | Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…CIX · Traditional | Alfa Wassermann Diagnostics Technologies, LLC | 08/19/2013SE |
| K113374 | Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace…CIX · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 07/13/2012SE |
| K110818 | Poly-Chem 90 Albumin, Bun, Calcium, Carbon Dioxide, Creatinine, and Total Protein TestsCIX · Traditional | Polymedco, Inc. | 09/08/2011SE |
| K110830 | Elitech Clinical Systems Calcium Arsenazo; Elitech Clinical Systems Albumin; Elitech…CIX · Traditional | Elitechgroup | 06/21/2011SE |
| K101088 | Easyra Albumin, Calcium, Magnesium and Inorganic Phosphorous ReagentCIX · Traditional | Medica Corp. | 04/04/2011SE |
More from Medica Corp.
| 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 |
| 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 |
| K802518 | Bun Reagent Astra 4 & 8 AnalyzersCDN · Traditional | 11/12/1980SE |
| K801346 | Nsi Reagent System for Ortho ELT-8 HemaGIF · Traditional | 08/12/1980SE |
Questions and answers
When was Nsi Astra TM Albumin Reagent Kit Nsi Item # 7926 cleared by the FDA?
Nsi Astra TM Albumin Reagent Kit Nsi Item # 7926 (K854718) received a 510(k) decision of Substantially Equivalent on December 19, 1985, 27 days after the submission was received.
What is the product code of K854718?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.