Solid Phase Deter Serum Cholesterol FR Whole Blood
FDA 510(k) K864159 · Chem-Elec, Inc.
510(k) numberK864159
Submission
- Device name
- Solid Phase Deter Serum Cholesterol FR Whole Blood
- Applicant
- Chem-Elec, Inc.
North Webster, IN, US - Received
- October 23, 1986
- Decision date
- June 10, 1988
- 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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| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
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|---|---|---|
| K943503 | Chemcard Glucose TestCGA · Traditional | 07/23/1996SE |
| K811406 | Creatinine Rate Reagent KitCGX · Traditional | 08/13/1981SE |
| K811381 | AstraJFL · Traditional | 08/13/1981SE |
| K811319 | Chloride Reagent KitJFS · Traditional | 08/13/1981SE |
| K811165 | Glucose Oxidase Rate ReagentCGA · Traditional | 08/13/1981SE |
| K811310 | Sodium/Potassium Reagent KitsCEM · Traditional | 07/10/1981SE |
| K811193 | Bun Rate ReagentCDS · Traditional | 07/10/1981SE |
| K811701 | Chloride/Carbon Dioxide Rate ReagentJFS · Traditional | 07/01/1981SE |
Questions and answers
When was Solid Phase Deter Serum Cholesterol FR Whole Blood cleared by the FDA?
Solid Phase Deter Serum Cholesterol FR Whole Blood (K864159) received a 510(k) decision of Substantially Equivalent on June 10, 1988, 596 days after the submission was received.
What is the product code of K864159?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.