Albumeter
FDA 510(k) K863050 · J. D. Assoc.
510(k) numberK863050
Submission
- Device name
- Albumeter
- Applicant
- J. D. Assoc.
Montclair, NJ, US - Received
- August 12, 1986
- Decision date
- September 11, 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 |
|---|---|---|
| K863103 | Peg 6,000CHH · Traditional | 01/13/1987SE |
| K863054 | Ast S.C.E. (Got)CIT · Traditional | 01/13/1987SE |
| K863069 | MagnesiometerJGJ · Traditional | 12/31/1986SE |
| K863079 | CreatinkineticCGX · Traditional | 12/12/1986SE |
| K863112 | ProteinmeterJGP · Traditional | 12/10/1986SE |
| K863068 | LDH S.C.E.CFJ · Traditional | 12/10/1986SE |
| K863053 | Alt S.C.E. (GPT)CKA · Traditional | 12/10/1986SE |
| K863066 | TransfermeterJQF · Traditional | 12/04/1986SE |
| K863109 | FerrofastJIY · Traditional | 11/24/1986SE |
| K863102 | Glucometer-ECGA · Traditional | 11/24/1986SE |
Questions and answers
When was Albumeter cleared by the FDA?
Albumeter (K863050) received a 510(k) decision of Substantially Equivalent on September 11, 1986, 30 days after the submission was received.
What is the product code of K863050?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.