In Vitro Digoxin Ria Test
FDA 510(k) K772110 · Clinical Assays, Inc.
510(k) numberK772110
Submission
- Device name
- In Vitro Digoxin Ria Test
- Applicant
- Clinical Assays, Inc.
Mchenry, IL, US - Received
- November 7, 1977
- Decision date
- November 22, 1977
- 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 |
| K781495 | Rianen Assay System, 125I KitDNL · Traditional | New England Nuclear | 09/14/1978SE |
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|---|---|---|
| K832712 | Folate Radioassay Kit CA-1562-125CGN · Traditional | 10/04/1983SE |
| K832711 | Vitamin B12 Folate CA-1515-125CDD · Traditional | 10/04/1983SE |
| K832710 | Vitamin B12 Radioassay Kit CA-1534CDD · Traditional | 10/04/1983SE |
| K823476 | Gammadab LH Radio-Kit #CA-1508CEP · Traditional | 12/28/1982SE |
| K823313 | In Vitro Gammacoat B-Hcg Radio. TestJHI · Traditional | 12/22/1982SE |
| K821611 | Gammadab [125] FSH Radioimmunay KitCGJ · Traditional | 06/24/1982SE |
| K821092 | GAMMADAB[125]EGE Radioimmunoassay ItDGC · Traditional | 06/22/1982SE |
| K812227 | Gammacoat (125) Insulin RadioimmunoassayCFP · Traditional | 09/24/1981SE |
| K810722 | Gastrin Radioimmunoassay TestCGC · Traditional | 05/27/1981SE |
| K810967 | In-Vitro TBG Radioimmunoassay TestCEE · Traditional | 04/23/1981SE |
Questions and answers
When was In Vitro Digoxin Ria Test cleared by the FDA?
In Vitro Digoxin Ria Test (K772110) received a 510(k) decision of Substantially Equivalent on November 22, 1977, 15 days after the submission was received.
What is the product code of K772110?
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.