Rianen Assay System, 125I Kit
FDA 510(k) K781495 · New England Nuclear
510(k) numberK781495
Submission
- Device name
- Rianen Assay System, 125I Kit
- Applicant
- New England Nuclear
Mchenry, IL, US - Received
- August 30, 1978
- Decision date
- September 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DNL – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DNL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852343 | Dig Radioimmunoassay Test SystemDNL · Traditional | M Nobird, Inc. | 07/09/1985SE |
| K852291 | Tipsep Digoxin RiaDNL · Traditional | Nuclear Diagnostics, Inc. | 06/25/1985SE |
| K811212 | Digoxin (Ria) KitDNL · Traditional | Immuno Assay Corp. | 05/21/1981SE |
| K810966 | Diagoxin Squibb Radioimmunoassay KitDNL · Traditional | E. R. Squibb & Sons, Inc. | 04/21/1981SE |
| K802841 | Digoxin Radioimmunoassay KitDNL · Traditional | American Diagnostic Corp. | 12/18/1980SE |
| K781834 | Test Set, 125 I-DigoxinDNL · Traditional | Wien Laboratories, Inc. | 01/03/1979SE |
| K772110 | In Vitro Digoxin Ria TestDNL · Traditional | Clinical Assays, Inc. | 11/22/1977SE |
More from Clinical Assays, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K841478 | Rianen Cyclic-Amp RadioimmunoassayCHO · Traditional | 06/14/1984SE |
| 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 |
Questions and answers
When was Rianen Assay System, 125I Kit cleared by the FDA?
Rianen Assay System, 125I Kit (K781495) received a 510(k) decision of Substantially Equivalent on September 14, 1978, 15 days after the submission was received.
What is the product code of K781495?
The FDA product code is DNL – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.