Chema Chol Cholesterol System
FDA 510(k) K904031 · Texas Intl. Laboratories, Inc.
510(k) numberK904031
Submission
- Device name
- Chema Chol Cholesterol System
- Applicant
- Texas Intl. Laboratories, Inc.
Houston, TX, US - Received
- August 31, 1990
- Decision date
- March 11, 1991
- 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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| 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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| K832886 | Flame Photometer T281-T282-T283JJO · Traditional | 12/08/1983SE |
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Questions and answers
When was Chema Chol Cholesterol System cleared by the FDA?
Chema Chol Cholesterol System (K904031) received a 510(k) decision of Substantially Equivalent on March 11, 1991, 192 days after the submission was received.
What is the product code of K904031?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.