Albumin Reagent Set
FDA 510(k) K880844 · Tech-Neal Scientific, Inc.
510(k) numberK880844
Submission
- Device name
- Albumin Reagent Set
- Applicant
- Tech-Neal Scientific, Inc.
Westmont, IL, US - Received
- February 26, 1988
- Decision date
- April 5, 1988
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K882256 | Magnesium Reagent SetJGJ · Traditional | 08/08/1988SE |
| K882459 | Diazo, Colorimetric BilirubinCIG · Traditional | 08/02/1988SE |
| K881239 | Gamma Glutamyl Transferase Reagent SetJPZ · Traditional | 05/31/1988SE |
| K881241 | Total Bilirubin ReagentCIG · Traditional | 05/27/1988SE |
| K881240 | Chloride Reagent SetCHJ · Traditional | 04/28/1988SE |
| K881237 | Creatine Kinase (CK) Reagent SetJHX · Traditional | 04/28/1988SE |
| K880237 | CholesterolCHH · Traditional | 04/28/1988SE |
| K880277 | Uric Acid Reagent SetKNK · Traditional | 04/18/1988SE |
| K880845 | Calcium Reagent SetCIC · Traditional | 04/05/1988SE |
| K880843 | Creatinine Reagent Set (Kinetic)CGX · Traditional | 04/05/1988SE |
Questions and answers
When was Albumin Reagent Set cleared by the FDA?
Albumin Reagent Set (K880844) received a 510(k) decision of Substantially Equivalent on April 5, 1988, 39 days after the submission was received.
What is the product code of K880844?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.