Product Code: DOG
FDA class 2
21 CFR 862.3320
Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
Clinical Toxicology
The Radioimmunoassay for Digoxin using iodine-125 with rabbit antibody and polyethylene glycol separation is a laboratory test system that quantifies digoxin in patient serum using a polyethylene glycol (PEG) precipitation separation radioimmunoassay. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DOG, regulated under 21 CFR 862.3320, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
5
Years Active
5
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Basic Information
- Product Code
- DOG
- Device Class
- FDA class 2
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K810477 | DCA DIGOX-SYN RIA TEST | Mar 11, 1981 | Substantially Equivalent | Diagnostic Corp. of America |
| K803045 | IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. | Dec 22, 1980 | Substantially Equivalent | American Dade |
| K781335 | DIGOXIN RIA (PEG) KIT | Aug 31, 1978 | Substantially Equivalent | Ortho Diagnostics, Inc. |
| K760709 | EMIT DIGOKIN ASSAY | Oct 21, 1976 | Substantially Equivalent | Syva Co. |
| K760416 | DATA-TOPE SYSTEM DIGOXIN RIA | Aug 23, 1976 | Substantially Equivalent | Dade, Baxter Travenol Diagnostics, Inc. |