Cholesterol Rapid Slat Kit HDL
FDA 510(k) K780331 · Pierce Chemical Co.
510(k) numberK780331
Submission
- Device name
- Cholesterol Rapid Slat Kit HDL
- Applicant
- Pierce Chemical Co.
- Received
- February 28, 1978
- Decision date
- April 6, 1978
- 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 |
| K232404 | CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESCHH · Traditional | Medicon Hellas S.A | 08/09/2024SE |
| 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 |
More from Axis-Shield Poc AS
| 510(k) | Device | Decision |
|---|---|---|
| K895661 | Glycotest II Glyhb Assay KitLCP · Traditional | 12/07/1989SE |
| K831837 | Clinovative II Diagnostic KitLCP · Traditional | 08/01/1983SE |
| K821360 | Glyco-Gel Test KitLCP · Traditional | 06/02/1982SE |
| K820279 | Glyco-Gel Test KitLCP · Traditional | 04/08/1982SE |
| K781897 | Stat Kit, MicroproteinCEK · Traditional | 01/10/1979SE |
| K780827 | Uric Acid Rapid Stat KitKNK · Traditional | 06/13/1978SE |
| K780826 | Bilirubin Rapid Stat KitCIG · Traditional | 05/26/1978SE |
| K780825 | Triglyceride C-37 Rapid Stat KitJGY · Traditional | 05/26/1978SE |
| K780512 | Auto/Stat KitCGA · Traditional | 05/03/1978SE |
Questions and answers
When was Cholesterol Rapid Slat Kit HDL cleared by the FDA?
Cholesterol Rapid Slat Kit HDL (K780331) received a 510(k) decision of Substantially Equivalent on April 6, 1978, 37 days after the submission was received.
What is the product code of K780331?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.