Albumin
FDA 510(k) K850931 · Dilab, Inc.
510(k) numberK850931
Submission
- Device name
- Albumin
- Applicant
- Dilab, Inc.
Miami, FL, US - Received
- March 7, 1985
- Decision date
- June 26, 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
| 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 |
|---|---|---|
| K862530 | Rapid AS LatexGTQ · Traditional | 04/21/1987SE |
| K850938 | CholesterolCGO · Traditional | 06/25/1985SE |
| K850936 | Total ProteinsCEK · Traditional | 06/25/1985SE |
| K850934 | PhosphorusCEO · Traditional | 06/25/1985SE |
| K850933 | Uric AcidCDH · Traditional | 06/25/1985SE |
| K850932 | CreatinineCGX · Traditional | 06/25/1985SE |
| K850937 | UreaCDW · Traditional | 06/10/1985SE |
| K850935 | ChlorideCHJ · Traditional | 06/10/1985SE |
| K850930 | GlucoseCGE · Traditional | 06/10/1985SE |
| K850929 | CalciumCIC · Traditional | 06/10/1985SE |
Questions and answers
When was Albumin cleared by the FDA?
Albumin (K850931) received a 510(k) decision of Substantially Equivalent on June 26, 1985, 111 days after the submission was received.
What is the product code of K850931?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.