Multichem Enzymatic Cholesterol Sys
FDA 510(k) K831700 · Simmler, Inc.
510(k) numberK831700
Submission
- Device name
- Multichem Enzymatic Cholesterol Sys
- Applicant
- Simmler, Inc.
Mchenry, IL, US - Received
- May 24, 1983
- Decision date
- July 19, 1983
- 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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| 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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| 510(k) | Device | Decision |
|---|---|---|
| K895745 | Sickle Cell Solubility Test KitJBB · Traditional | 11/29/1989SE |
| K874903 | Multichem(R) Y -Glutamyltransferase (Y -Gt)JPZ · Traditional | 02/11/1988SE |
| K874595 | Multichem (R) Magnesium ReagentJGJ · Traditional | 01/21/1988SE |
| K874820 | Multichem HDL Precipitating Reagent #S0914LBR · Traditional | 01/07/1988SE |
| K874812 | Multichem Chloride Reagent S0933CHJ · Traditional | 12/18/1987SE |
| K874311 | Multichem (R) Total BilirubinCIG · Traditional | 11/25/1987SE |
| K874049 | Multichem Albumin Reagent S0902CIX · Traditional | 10/29/1987SE |
| K874038 | Multichem Inorganic Phosphorous S0923CEO · Traditional | 10/28/1987SE |
| K873725 | Multichem Creatinine Reagent S0917CGX · Traditional | 10/20/1987SE |
| K873761 | Multichem Alkaline Phosphatase (S0903)CJE · Traditional | 10/07/1987SE |
Questions and answers
When was Multichem Enzymatic Cholesterol Sys cleared by the FDA?
Multichem Enzymatic Cholesterol Sys (K831700) received a 510(k) decision of Substantially Equivalent on July 19, 1983, 56 days after the submission was received.
What is the product code of K831700?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.