Dig Radioimmunoassay Test System
FDA 510(k) K852343 · M Nobird, Inc.
510(k) numberK852343
Submission
- Device name
- Dig Radioimmunoassay Test System
- Applicant
- M Nobird, Inc.
Costa Mesa, CA, US - Received
- June 3, 1985
- Decision date
- July 9, 1985
- 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 |
|---|---|---|---|
| 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 |
| K781495 | Rianen Assay System, 125I KitDNL · Traditional | New England Nuclear | 09/14/1978SE |
| K772110 | In Vitro Digoxin Ria TestDNL · Traditional | Clinical Assays, Inc. | 11/22/1977SE |
Questions and answers
When was Dig Radioimmunoassay Test System cleared by the FDA?
Dig Radioimmunoassay Test System (K852343) received a 510(k) decision of Substantially Equivalent on July 9, 1985, 36 days after the submission was received.
What is the product code of K852343?
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.