Sandare BCG Albumin Procedure
FDA 510(k) K860684 · Sandare Chemical Co., Inc.
510(k) numberK860684
Submission
- Device name
- Sandare BCG Albumin Procedure
- Applicant
- Sandare Chemical Co., Inc.
Desoto, TX, US - Received
- February 25, 1986
- Decision date
- March 17, 1986
- 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 |
|---|---|---|
| K872852 | Eagle Diagnostics Glycohemoglobin Unitized TestLCP · Traditional | 09/29/1987SE |
| K862556 | Sandare Glycohemoglobin ProcedureLCP · Traditional | 08/08/1986SE |
| K851395 | Sandare Iron-Binding Capacity ProcedureJMO · Traditional | 05/07/1985SE |
| K851394 | Sandare Iron ProcedureJIY · Traditional | 04/30/1985SE |
| K844498 | Sandare Alkaline Phosphatase ProcedureCIO · Traditional | 12/10/1984SE |
| K842516 | Sandare Acid Phosphatase ProcedureCJR · Traditional | 08/17/1984SE |
| K833898 | Tri-Level Bilirubin ControlsJJX · Traditional | 01/13/1984SE |
| K832942 | Total & Direct Bilirubin ProceduresCIG · Traditional | 11/07/1983SE |
| K832632 | Albumin Procedure BCPCJW · Traditional | 09/12/1983SE |
| K832183 | Sandare Calcium ProcedureCIC · Traditional | 08/24/1983SE |
Questions and answers
When was Sandare BCG Albumin Procedure cleared by the FDA?
Sandare BCG Albumin Procedure (K860684) received a 510(k) decision of Substantially Equivalent on March 17, 1986, 20 days after the submission was received.
What is the product code of K860684?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.