Quikread Chem. Analyzer & Choles. for Whole Blood
FDA 510(k) K890027 · Photec Diagnostics, Inc.
510(k) numberK890027
Submission
- Device name
- Quikread Chem. Analyzer & Choles. for Whole Blood
- Applicant
- Photec Diagnostics, Inc.
Little Falls, NJ, US - Received
- January 4, 1989
- Decision date
- April 26, 1989
- 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 |
| 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 |
|---|---|---|
| K897169 | Quikread(R) Whole Blood Triglyceride Test KitCDT · Traditional | 02/23/1990SE |
| K896329 | D-Chem Total T4 Test Kit for Thyroxine Quantita.KLI · Traditional | 12/12/1989SE |
| K894057 | Quikread Whole Blood Hdl-Cholesterol Test KitLBS · Traditional | 08/31/1989SE |
| K892224 | D-Chem(Tm) T-Uptake Test Kit for T-Uptake DeterminKHQ · Traditional | 06/16/1989SE |
| K890267 | Quikread Chem. Analyzer & Choles. for Serum/PlasmaCHH · Traditional | 04/26/1989SE |
| K882307 | D-ChemJJE · Traditional | 08/02/1988SE |
| K880291 | Theophylline Test Kit Ref. #A874799LCA · Traditional | 03/24/1988SE |
| K854875 | Apo-Screen Calibrator & Control Set for HDL Apo A1DER · Traditional | 01/24/1986SE |
| K853048 | Apo-Screen Test Set for Hdl-Apolipoptein A-1DER · Traditional | 08/28/1985SE |
| K853174 | Apo-Chrome Immunoassay Test Set for ApolipoproteinMSJ · Traditional | 08/22/1985SE |
Questions and answers
When was Quikread Chem. Analyzer & Choles. for Whole Blood cleared by the FDA?
Quikread Chem. Analyzer & Choles. for Whole Blood (K890027) received a 510(k) decision of Substantially Equivalent on April 26, 1989, 112 days after the submission was received.
What is the product code of K890027?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.