Phase II Theophylline Radioimmunoassay
FDA 510(k) K833789 · Medical & Scientific Designs, Inc.
510(k) numberK833789
Submission
- Device name
- Phase II Theophylline Radioimmunoassay
- Applicant
- Medical & Scientific Designs, Inc.
Mchenry, IL, US - Received
- October 31, 1983
- Decision date
- January 24, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCA – Radioimmunoassay, Theophylline
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3880
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LCA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880291 | Theophylline Test Kit Ref. #A874799LCA · Traditional | Photec Diagnostics, Inc. | 03/24/1988SE |
| K821862 | Quanticoat 125 I-Theophylline Radioimm.LCA · Traditional | Kallestad Laboratories, Inc. | 07/06/1982SE |
| K821347 | Bio-Mag Theophylline (125I) Radioimmun.LCA · Traditional | Bioclinical Corp. | 05/28/1982SE |
| K792062 | Theophylline RiassayLCA · Traditional | Ria Diagnostics | 02/25/1980SE |
More from Ria Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K862960 | Phase II Ferritin Radioimmunoassay KitDBF · Traditional | 08/27/1986SE |
| K853224 | Phase II B-12/FOLATE KitCDD · Traditional | 10/03/1985SE |
| K840901 | Phase II Free T4 KitCEC · Traditional | 04/25/1984SE |
| K840328 | Phase II HCG KitJHI · Traditional | 04/19/1984SE |
| K834219 | Phase II Cortisol KitCGR · Traditional | 02/04/1984SE |
| K832499 | Phase II TSH KitJLW · Traditional | 09/12/1983SE |
| K832210 | Gamma Photon Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K832209 | Kineti Count 24 Gamma CounterJJJ · Traditional | 08/24/1983SE |
| K831064 | Phase II T3 Radioimmunoassay KitCDP · Traditional | 05/09/1983SE |
| K830900 | Uptake T3 Radioimmunoassay KitKHQ · Traditional | 04/18/1983SE |
Questions and answers
When was Phase II Theophylline Radioimmunoassay cleared by the FDA?
Phase II Theophylline Radioimmunoassay (K833789) received a 510(k) decision of Substantially Equivalent on January 24, 1984, 85 days after the submission was received.
What is the product code of K833789?
The FDA product code is LCA – Radioimmunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.