Rianen Cyclic-Amp Radioimmunoassay
FDA 510(k) K841478 · New England Nuclear
510(k) numberK841478
Submission
- Device name
- Rianen Cyclic-Amp Radioimmunoassay
- Applicant
- New England Nuclear
Mchenry, IL, US - Received
- April 9, 1984
- Decision date
- June 14, 1984
- 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 |
| K823504 | Cyclic Adenosine Monophoshate by RadioCHO · Traditional | Immuno Nuclear Corp. | 01/28/1983SE |
| K811746 | King Diagnostics Cholesterol-Fe TestCHO · Traditional | King Diagnostics, Inc. | 07/10/1981SE |
| K811273 | Cyclic Amp Radioimmunoassay Kit [125I]CHO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/27/1981SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K840301 | Rianen Estriol Radioimmunoassay KitCGI · Traditional | 03/30/1984SE |
| K834038 | Rianen Follicle Stimulating HormoneCGJ · Traditional | 01/30/1984SE |
| K833376 | Rianen Luteinizing Hormone Ria KitCEP · Traditional | 12/20/1983SE |
| K831345 | Rianen Prolactin 125I KitCFT · Traditional | 06/08/1983SE |
| K801245 | Atomlight (Liquid Scintillation SolutionJJJ · Traditional | 06/20/1980SE |
| K792175 | Rianen, Vitamin B12 Assay SystemCDD · Traditional | 11/13/1979SE |
| K790817 | Ria Kit, Quantitation of Prostatic AcidJFH · Traditional | 05/07/1979SE |
| K782110 | Ria Kit, Rianen CortisolCGR · Traditional | 01/26/1979SE |
| K781888 | Assay System, Ferritin I KitJMG · Traditional | 01/10/1979SE |
| K781495 | Rianen Assay System, 125I KitDNL · Traditional | 09/14/1978SE |
Questions and answers
When was Rianen Cyclic-Amp Radioimmunoassay cleared by the FDA?
Rianen Cyclic-Amp Radioimmunoassay (K841478) received a 510(k) decision of Substantially Equivalent on June 14, 1984, 66 days after the submission was received.
What is the product code of K841478?
The FDA product code is CHO – Radioimmunoassay, Cyclic Amp, a Class II (moderate risk) device regulated under 21 CFR 862.1230.