Digoxin Standards in Human Serum
FDA 510(k) K780889 · Pcl-Ria, Inc.
510(k) numberK780889
Submission
- Device name
- Digoxin Standards in Human Serum
- Applicant
- Pcl-Ria, Inc.
Mchenry, IL, US - Received
- May 31, 1978
- Decision date
- August 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DMP – Digoxin Control Serum, Ria
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973973 | Elecsys Callcheck DigoxinDMP · Traditional | Boehringer Mannheim Corp. | 11/04/1997SE |
| K953393 | Tox Perfect a TubeDMP · Traditional | Chimera Research & Chemical, Inc. | 10/06/1995SE |
| K770411 | Digi Trol Tm-Rx & Digi Trol Tm-TxDMP · Traditional | Nuclear Medical Laboratories, Inc. | 03/16/1977SE |
More from Nuclear Medical Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K830526 | B-Gcg System by RiaJHI · Traditional | 04/05/1983SE |
| K823014 | Digoxin KitDPB · Traditional | 11/01/1982SE |
| K822935 | Thyroid Stimulating HormoneJLW · Traditional | 11/01/1982SE |
| K822612 | T3 Uptake KitsKHQ · Traditional | 09/30/1982SE |
| K820886 | Thyroxine T4 KitCDX · Traditional | 04/16/1982SE |
| K820358 | Follicle Stimulating Hormone KitCGJ · Traditional | 03/26/1982SE |
| K820357 | Luteinizing Hormone KitCEP · Traditional | 03/25/1982SE |
| K812666 | Thyroxine (T4) 125ICDP · Traditional | 10/02/1981SE |
| K810867 | Follicle Stimulating Hormone (FSH)JIS · Traditional | 04/14/1981SE |
| K810852 | Follicle Stimulating Hormone AntiserumCGJ · Traditional | 04/08/1981SE |
Questions and answers
When was Digoxin Standards in Human Serum cleared by the FDA?
Digoxin Standards in Human Serum (K780889) received a 510(k) decision of Substantially Equivalent on August 14, 1978, 75 days after the submission was received.
What is the product code of K780889?
The FDA product code is DMP – Digoxin Control Serum, Ria, a Class I (low risk) device regulated under 21 CFR 862.3280.