Cholesterol Aqueous Standard
FDA 510(k) K840217 · Preventive Diagnostics Corp.
510(k) numberK840217
Submission
- Device name
- Cholesterol Aqueous Standard
- Applicant
- Preventive Diagnostics Corp.
Mchenry, IL, US - Received
- January 19, 1984
- Decision date
- March 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIS – Calibrator, Primary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122126 | Direct Ldl/Hdl Cholesterol CalibratorJIS · Traditional | Randox Laboratories Limited | 08/14/2012SE |
| K061251 | Dimension Vista Total Iron Binding Capacity CalibratorJIS · Traditional | Dade Behring, Inc. | 05/31/2006SE |
| K060266 | Dimension Iron CalibratorJIS · Traditional | Dade Behring, Inc. | 03/09/2006SE |
| K053104 | Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorJIS · Traditional | Dade Behring, Inc. | 12/23/2005SE |
| K032697 | Dimension Total Triiodothyronine Calibrator (RC414)JIS · Traditional | Dade Behring, Inc. | 11/07/2003SE |
| K032608 | Gonotec Calibration Solution 300 Mosmol/Kg for OsmometerJIS · Abbreviated | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 10/21/2003SE |
| K032296 | Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special | Ortho-Clinical Diagnostics, Inc. | 08/13/2003SE |
| K030964 | Calibration Plasma LMW HeparinJIS · Traditional | Instrumentation Laboratory CO | 06/06/2003SE |
| K030546 | CRP (II) CalibratorsJIS · Traditional | Denka Seiken Co., Ltd. | 06/02/2003SE |
| K030320 | Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control SetJIS · Traditional | Wako Chemicals USA, Inc. | 04/11/2003SE |
More from Wako Chemicals USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K840677 | HDL EZ-TZ3 Cholesterol Reagent KitLBS · Traditional | 04/13/1984SE |
| K840676 | PDC HDL Ez-Sep Cholesterol ReagentLBS · Traditional | 04/04/1984SE |
| K840991 | Preserv Buffered Glycerol SalineJTW · Traditional | 03/23/1984SE |
| K840990 | Preserv Cary Blair Transport PackJTW · Traditional | 03/23/1984SE |
| K840968 | Preserv Transport & Culture PackJTW · Traditional | 03/23/1984SE |
| K840278 | HDL Cholesterol Controls-LevelsJIX · Traditional | 03/23/1984SE |
| K840220 | HDL Cholesterol Aqueous StandardsJIS · Traditional | 03/23/1984SE |
| K840219 | Triglyceride/Cholesterol AqueousJIX · Traditional | 03/23/1984SE |
| K840218 | Triglyceride Aqueous StandardsJIT · Traditional | 03/23/1984SE |
| K840189 | Total Cholesterol Reagent SetCHH · Traditional | 03/23/1984SE |
Questions and answers
When was Cholesterol Aqueous Standard cleared by the FDA?
Cholesterol Aqueous Standard (K840217) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 64 days after the submission was received.
What is the product code of K840217?
The FDA product code is JIS – Calibrator, Primary, a Class II (moderate risk) device regulated under 21 CFR 862.1150.