Kodak Ektachem Clinical Chemistry Slides
FDA 510(k) K820263 · Eastman Kodak Company
510(k) numberK820263
Submission
- Device name
- Kodak Ektachem Clinical Chemistry Slides
- Applicant
- Eastman Kodak Company
Mchenry, IL, US - Received
- February 2, 1982
- Decision date
- February 18, 1982
- 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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| K251091 | LipidsCHH · Traditional | Truvian Health | 12/30/2025SE |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESCHH · Traditional | Medicon Hellas S.A | 08/09/2024SE |
| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/27/2019SE |
| K181373 | Extended Lipid Panel AssayCHH · Traditional | Laboratory Corporation of America Holdings | 10/18/2018SE |
| K180504 | Mission Lipid Panel Monitoring SystemCHH · Special | ACON Laboratories, Inc. | 03/28/2018SE |
| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH · Traditional | ACON Laboratories, Inc. | 07/11/2017SE |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | Polymer Technology Systems, Inc. | 12/22/2016SE |
| 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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| K051483 | Kodak Directview DR System DetectorMQB · Traditional | 06/21/2005SE |
| K051258 | Kodak Directview DR 7500 System, Model 8791345KPR · Special | 06/01/2005SE |
| K042159 | Kodak Color Medical Imager 1000LMC · Traditional | 09/24/2004SE |
| K042158 | Kodak Medical Imager 300LMC · Traditional | 09/24/2004SE |
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Questions and answers
When was Kodak Ektachem Clinical Chemistry Slides cleared by the FDA?
Kodak Ektachem Clinical Chemistry Slides (K820263) received a 510(k) decision of Substantially Equivalent on February 18, 1982, 16 days after the submission was received.
What is the product code of K820263?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.