Bio-Mag Theophylline (125I) Radioimmun.
FDA 510(k) K821347 · Bioclinical Corp.
510(k) numberK821347
Submission
- Device name
- Bio-Mag Theophylline (125I) Radioimmun.
- Applicant
- Bioclinical Corp.
Mchenry, IL, US - Received
- May 5, 1982
- Decision date
- May 28, 1982
- 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 |
| K833789 | Phase II Theophylline RadioimmunoassayLCA · Traditional | Medical & Scientific Designs, Inc. | 01/24/1984SE |
| K821862 | Quanticoat 125 I-Theophylline Radioimm.LCA · Traditional | Kallestad Laboratories, Inc. | 07/06/1982SE |
| K792062 | Theophylline RiassayLCA · Traditional | Ria Diagnostics | 02/25/1980SE |
Questions and answers
When was Bio-Mag Theophylline (125I) Radioimmun. cleared by the FDA?
Bio-Mag Theophylline (125I) Radioimmun. (K821347) received a 510(k) decision of Substantially Equivalent on May 28, 1982, 23 days after the submission was received.
What is the product code of K821347?
The FDA product code is LCA – Radioimmunoassay, Theophylline, a Class II (moderate risk) device regulated under 21 CFR 862.3880.