King Diagnostics Cholesterol Reagent Strip Test
FDA 510(k) K912499 · King Diagnostics, Inc.
510(k) numberK912499
Submission
- Device name
- King Diagnostics Cholesterol Reagent Strip Test
- Applicant
- King Diagnostics, Inc.
Indianapolis, IN, US - Received
- June 5, 1991
- Decision date
- September 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/27/2019SE |
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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 |
More from Axis-Shield Poc AS
| 510(k) | Device | Decision |
|---|---|---|
| K933329 | King Diagnostics Iron and Total Iron Binding Capacity ReagentJMO · Traditional | 10/22/1993SE |
| K931834 | King Sodium/Potassium Standard ModifiedJIS · Traditional | 08/25/1993SE |
| K931773 | HDL Precipitating Reagent (Dextran Sulfate)LBR · Traditional | 08/16/1993SE |
| K931326 | King Diagnostics CK ReagentCGS · Traditional | 06/15/1993SE |
| K923129 | King Diagnostics Glucose (HK) ReagentCFR · Traditional | 11/02/1992SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | 10/13/1992SE |
| K922921 | King Diagnostics Chloride ReagentCHJ · Traditional | 10/05/1992SE |
| K923927 | King Diagnostics Magnesium ReagentJGJ · Traditional | 09/30/1992SE |
| K923128 | King Diagnostics Cholesterol ReagentCHH · Traditional | 09/09/1992SE |
| K923091 | King Diagnostics Gamma GT ReagentJPZ · Traditional | 09/09/1992SE |
Questions and answers
When was King Diagnostics Cholesterol Reagent Strip Test cleared by the FDA?
King Diagnostics Cholesterol Reagent Strip Test (K912499) received a 510(k) decision of Substantially Equivalent on September 27, 1991, 114 days after the submission was received.
What is the product code of K912499?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.