King Diagnostics Cholesterol-Fe Test
FDA 510(k) K811746 · King Diagnostics, Inc.
510(k) numberK811746
Submission
- Device name
- King Diagnostics Cholesterol-Fe Test
- Applicant
- King Diagnostics, Inc.
Mchenry, IL, US - Received
- June 22, 1981
- Decision date
- July 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHO – Radioimmunoassay, Cyclic Amp
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1230
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860253 | Amerlex-M CAMP(125)ASSAY System RPA.508 (100 Kit)CHO · Traditional | Amersham Corp. | 03/14/1986SE |
| K844135 | Plasma Cyclic Adenosine Monophosphate by RadioimmuCHO · Traditional | Immuno Nuclear Corp. | 03/05/1985SE |
| K841478 | Rianen Cyclic-Amp RadioimmunoassayCHO · Traditional | New England Nuclear | 06/14/1984SE |
| K823504 | Cyclic Adenosine Monophoshate by RadioCHO · Traditional | Immuno Nuclear Corp. | 01/28/1983SE |
| K811273 | Cyclic Amp Radioimmunoassay Kit [125I]CHO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/27/1981SE |
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| K931326 | King Diagnostics CK ReagentCGS · Traditional | 06/15/1993SE |
| K923129 | King Diagnostics Glucose (HK) ReagentCFR · Traditional | 11/02/1992SE |
| K922969 | King Diagnostics Urea Nitrogen ReagentCDN · Traditional | 10/13/1992SE |
| K922921 | King Diagnostics Chloride ReagentCHJ · Traditional | 10/05/1992SE |
| K923927 | King Diagnostics Magnesium ReagentJGJ · Traditional | 09/30/1992SE |
| K923128 | King Diagnostics Cholesterol ReagentCHH · Traditional | 09/09/1992SE |
| K923091 | King Diagnostics Gamma GT ReagentJPZ · Traditional | 09/09/1992SE |
Questions and answers
When was King Diagnostics Cholesterol-Fe Test cleared by the FDA?
King Diagnostics Cholesterol-Fe Test (K811746) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 18 days after the submission was received.
What is the product code of K811746?
The FDA product code is CHO – Radioimmunoassay, Cyclic Amp, a Class II (moderate risk) device regulated under 21 CFR 862.1230.