Amerlex Digoxin Ria Kit
FDA 510(k) K801413 · Amersham Corp.
510(k) numberK801413
Submission
- Device name
- Amerlex Digoxin Ria Kit
- Applicant
- Amersham Corp.
Mchenry, IL, US - Received
- June 16, 1980
- Decision date
- July 8, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCS – Radioimmunoassay, Digoxin (125-I)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LCS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K922353 | Digoxin Coated Tube RiaLCS · Traditional | Monobind | 08/24/1992SE |
| K913562 | QMS - DigoxinLCS · Traditional | Seradyn, Inc. | 08/30/1991SE |
| K895828 | Innofluor Digoxin Reagent SetLCS · Traditional | Innotron of Oregon, Inc. | 10/30/1989SE |
| K884707 | Fiagen Digoxin Time-Resolved Fluoroimmunoassay KitLCS · Traditional | Cyberfluor, Inc. | 01/17/1989SE |
| K874748 | Immpulse Digoxin Assay ReagentsLCS · Traditional | Sclavo, Inc. | 02/19/1988SE |
| K864802 | Dart Digoxin AssayLCS · Traditional | Coulter Electronics, Inc. | 02/12/1987SE |
| K820154 | TDX DigoxinLCS · Traditional | Abbott Laboratories | 02/05/1982SE |
| K812749 | Ultra-DigLCS · Traditional | Antibodies, Inc. | 10/19/1981SE |
| K803047 | I-125 Labeled DigoxinLCS · Traditional | Pcl-Ria, Inc. | 12/22/1980SE |
| K801490 | Digoxin Eia KitLCS · Traditional | M.A. Bioproducts | 07/14/1980SE |
More from M.A. Bioproducts
| 510(k) | Device | Decision |
|---|---|---|
| K914135 | Amerlite(Tm) PROLACTIN-30 Assay, LAN.0086/2086CFT · Traditional | 02/18/1992SE |
| K912733 | Amerlex-M Specific Estrol(Unconjugated) Ria KitCIG · Traditional | 07/22/1991SE |
| K912766 | Amerlite Ck-Mb AssayJHY · Traditional | 07/17/1991SE |
| K904666 | Amerlite TSH-60 Assay Product Code: Lan. 0008/2008JLW · Traditional | 11/02/1990SE |
| K902760 | Amersham TSH Control SeraJJX · Traditional | 07/27/1990SE |
| K901857 | GADOLINIUM-153 Bone Densitometer (GDC.10413)KGI · Traditional | 07/09/1990SE |
| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
| K901848 | GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional | 07/09/1990SE |
| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | 12/12/1989SE |
Questions and answers
When was Amerlex Digoxin Ria Kit cleared by the FDA?
Amerlex Digoxin Ria Kit (K801413) received a 510(k) decision of Substantially Equivalent on July 8, 1980, 22 days after the submission was received.
What is the product code of K801413?
The FDA product code is LCS – Radioimmunoassay, Digoxin (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3320.