Product Code: DMP
FDA class 1
21 CFR 862.3280
Digoxin Control Serum, Ria
Clinical Toxicology
The Digoxin Control Serum for Radioimmunoassay is a quality control material used in clinical laboratories to monitor the performance and accuracy of digoxin radioimmunoassay test systems. It is a Class 1 device subject only to general controls and does not require premarket notification. The product code is DMP, regulated under 21 CFR 862.3280, within the Clinical Toxicology specialty. No special regulatory flags apply.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
21
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Basic Information
- Product Code
- DMP
- Device Class
- FDA class 1
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 4
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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K973973 | ELECSYS CALLCHECK DIGOXIN | Nov 04, 1997 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K953393 | TOX PERFECT A TUBE | Oct 06, 1995 | Substantially Equivalent | Chimera Research & Chemical, Inc. |
| K780889 | DIGOXIN STANDARDS IN HUMAN SERUM | Aug 14, 1978 | Substantially Equivalent | Pcl-Ria, Inc. |
| K770411 | DIGI TROL TM-RX & DIGI TROL TM-TX | Mar 16, 1977 | Substantially Equivalent | Nuclear Medical Laboratories, Inc. |