Wisp Model 710
FDA 510(k) K772311 · Waters Assoc., Inc.
510(k) numberK772311
Submission
- Device name
- Wisp Model 710
- Applicant
- Waters Assoc., Inc.
- Received
- December 19, 1977
- Decision date
- January 12, 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 |
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| K811975 | Model 480 Variable Wavelength Ultra ViolJJQ · Traditional | 07/27/1981SE |
| K802481 | 7FRENCH Flow Directed Triple Lumen CathDYG · Traditional | 10/31/1980SE |
| K801852 | MRM-2 Oxygen Consumption MonitorBZL · Traditional | 08/20/1980SE |
| K801431 | Pan-Am Myelogram TrayFMI · Traditional | 08/12/1980SE |
| K791661 | System Controller 720 SeriesKIE · Traditional | 09/24/1979SE |
| K791026 | 4F Sterile Balloon-Less, Catheter 913-28KRB · Traditional | 06/22/1979SE |
| K790145 | Solvent Delivery SystemKIE · Traditional | 02/15/1979SE |
| K782175 | Cartridge Holder, RCM 100KIE · Traditional | 02/15/1979SE |
| K781805 | Cardiac Computers, CO-10 & CO-10RDXG · Traditional | 01/29/1979SE |
| K781915 | Data ModuleKIE · Traditional | 01/10/1979SE |
Questions and answers
When was Wisp Model 710 cleared by the FDA?
Wisp Model 710 (K772311) received a 510(k) decision of Substantially Equivalent on January 12, 1978, 24 days after the submission was received.
What is the product code of K772311?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.