Centrifichem Cholesterol
FDA 510(k) K800765 · Union Carbide Corp.
510(k) numberK800765
Submission
- Device name
- Centrifichem Cholesterol
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- April 7, 1980
- Decision date
- April 24, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
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| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
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| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional | Axis-Shield Poc AS | 03/21/2014SE |
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| K820535 | Laser Gas MixturesEWG · Traditional | 03/31/1982SE |
| K812536 | Linde Mark IIBYJ · Traditional | 09/23/1981SE |
| K810732 | Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional | 03/27/1981SE |
| K810596 | Centrifi Chem System 400 AnalyzerJJE · Traditional | 03/17/1981SE |
| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802741 | Centrifichem Comb. Serum-Based Calib.JIX · Traditional | 12/10/1980SE |
| K802520 | Centrifichem Pipettor Accuracy Calib.JQW · Traditional | 11/12/1980SE |
Questions and answers
When was Centrifichem Cholesterol cleared by the FDA?
Centrifichem Cholesterol (K800765) received a 510(k) decision of Substantially Equivalent on April 24, 1980, 17 days after the submission was received.
What is the product code of K800765?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.