Emit Digokin Assay
FDA 510(k) K760709 · Syva Co.
510(k) numberK760709
Submission
- Device name
- Emit Digokin Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- September 24, 1976
- Decision date
- October 21, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DOG – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DOG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K810477 | Dca Digox-Syn Ria TestDOG · Traditional | Diagnostic Corp. of America | 03/11/1981SE |
| K803045 | Immu-Trace Digoxin (125I) Radioimmun.DOG · Traditional | American Dade | 12/22/1980SE |
| K781335 | Digoxin Ria (Peg) KitDOG · Traditional | Ortho Diagnostics, Inc. | 08/31/1978SE |
| K760416 | Data-Tope System Digoxin RiaDOG · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 08/23/1976SE |
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Questions and answers
When was Emit Digokin Assay cleared by the FDA?
Emit Digokin Assay (K760709) received a 510(k) decision of Substantially Equivalent on October 21, 1976, 27 days after the submission was received.
What is the product code of K760709?
The FDA product code is DOG – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol, a Class II (moderate risk) device regulated under 21 CFR 862.3320.