Chem-Strate Cholesterol
FDA 510(k) K792478 · General Diagnostics
510(k) numberK792478
Submission
- Device name
- Chem-Strate Cholesterol
- Applicant
- General Diagnostics
Mchenry, IL, US - Received
- December 3, 1979
- Decision date
- December 27, 1979
- 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 |
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| 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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| K882663 | Barbiturate Enzyme Immunoassay KitDIS · Traditional | 09/19/1988SE |
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| K871305 | Cocaine Metabolite Enzyme Immunoassay KitDIO · Traditional | 06/05/1987SE |
| K864993 | Quali. Enzyme Immuno. of Barbiturates in UrineDIS · Traditional | 03/31/1987SE |
| K863877 | Benzodiazepine Enzyme Immunoassay KitJXM · Traditional | 03/12/1987SE |
| K842307 | General Diag. Cefonicid 30MCG AntimicJTN · Traditional | 07/20/1984SE |
| K841465 | General Diagnostics Platelet AntibodyLLG · Traditional | 07/02/1984SE |
| K833709 | Ceftizoxime 30 MCG Antimicrobial DiskJTN · Traditional | 12/30/1983SE |
| K832653 | Cefuroxime 30MCG. Suscep DiskJTN · Traditional | 10/14/1983SE |
| K831179 | Cefazolin 30MCG. Antimicrobial SuscepJTN · Traditional | 05/09/1983SE |
Questions and answers
When was Chem-Strate Cholesterol cleared by the FDA?
Chem-Strate Cholesterol (K792478) received a 510(k) decision of Substantially Equivalent on December 27, 1979, 24 days after the submission was received.
What is the product code of K792478?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.