Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride
FDA 510(k) K111753 · Hitachi Chemical Diagnostics, Inc.
510(k) numberK111753
Submission
- Device name
- Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride
- Applicant
- Hitachi Chemical Diagnostics, Inc.
Los Angeles, CA, US - Received
- June 22, 2011
- Decision date
- December 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code CHH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K193613 | Allergen-Specific IgE Assay 12 Allergen BundleDHB · Traditional | 10/18/2021SE |
| K182793 | AP3600 Automated InstrumentDHB · Traditional | 03/19/2019SE |
| K140248 | S Test Reagent Cartridge Carbon Dioxide (CO2)KHS · Traditional | 03/11/2014SE |
| K132462 | S Test Reagent Cartridge Bun and S Test Reagent Cartridge CreCDN · Traditional | 10/28/2013SE |
| K130685 | Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyJFJ · Traditional | 08/09/2013SE |
| K131217 | S Test Reagent Cartridge Total BilirubinCIG · Traditional | 06/07/2013SE |
| K131051 | Hitachi S Test Reagent Cartridge Total Protein (TP) and Albumin (Alb)JGQ · Traditional | 06/07/2013SE |
| K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…CKA · Traditional | 06/07/2013SE |
| K130870 | Hitachi Clinical Analyzer S Test Reagent Cartridge Calcium (Ca)CIC · Traditional | 05/02/2013SE |
| K130141 | S Test Reagent Cartridge Alp (Alkaline Phosphatase)CJE · Traditional | 03/22/2013SE |
Questions and answers
When was Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride cleared by the FDA?
Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride (K111753) received a 510(k) decision of Substantially Equivalent on December 14, 2011, 175 days after the submission was received.
What is the product code of K111753?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.