Radioimmunoassay, Cyclic Amp
The Radioimmunoassay, Cyclic AMP test system (product code CHO) is an in-vitro diagnostic device used in clinical chemistry to measure cyclic adenosine monophosphate (cAMP), a key intracellular second messenger, in biological specimens using a radioimmunoassay method. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1230 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
Research product code CHO in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- CHO
- Device Class
- FDA class 2
- Regulation Number
- 862.1230
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K860253 | AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) | Mar 14, 1986 | Substantially Equivalent | Amersham Corp. |
| K844135 | PLASMA CYCLIC ADENOSINE MONOPHOSPHATE BY RADIOIMMU | Mar 05, 1985 | Substantially Equivalent | Immuno Nuclear Corp. |
| K841478 | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY | Jun 14, 1984 | Substantially Equivalent | New England Nuclear |
| K823504 | CYCLIC ADENOSINE MONOPHOSHATE BY RADIO | Jan 28, 1983 | Substantially Equivalent | Immuno Nuclear Corp. |
| K811746 | KING DIAGNOSTICS CHOLESTEROL-FE TEST | Jul 10, 1981 | Substantially Equivalent | King Diagnostics, Inc. |
| K811273 | CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] | May 27, 1981 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |