Chemwell, Model 2900
FDA 510(k) K010877 · Awareness Technology, Inc.
510(k) numberK010877
Submission
- Device name
- Chemwell, Model 2900
- Applicant
- Awareness Technology, Inc.
Palm City, FL, US - Received
- March 23, 2001
- Decision date
- May 23, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CIX – Bromcresol Green Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
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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 |
|---|---|---|
| K171476 | SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)JGS · Traditional | 02/27/2018SE |
| K013420 | Chemwell, Also Known AS Project 2900JLW · Abbreviated | 07/19/2002SE |
| K974762 | Stat TracksJJQ · Traditional | 01/28/1998SE |
| K943729 | Dye Check Strips 545-630JJY · Traditional | 12/29/1994SE |
| K941394 | Stat Fax 2600JQW · Traditional | 06/03/1994SE |
| K923598 | Redi-Check Photmeter Q.A.JFS · Traditional | 10/14/1992SE |
| K900224 | Stat FAX(TM)-2100JJQ · Traditional | 03/01/1990SE |
| K892656 | Dri-Dye Check Strips (TM)-405JJX · Traditional | 05/22/1989SE |
| K882938 | Stat Fax(Tm)JJQ · Traditional | 09/09/1988SE |
| K873451 | Project 300 Microassay BP-12, Eia MinilabJJQ · Traditional | 11/04/1987SE |
Questions and answers
When was Chemwell, Model 2900 cleared by the FDA?
Chemwell, Model 2900 (K010877) received a 510(k) decision of Substantially Equivalent on May 23, 2001, 61 days after the submission was received.
What is the product code of K010877?
The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.