Fiagen Digoxin Time-Resolved Fluoroimmunoassay Kit
FDA 510(k) K884707 · Cyberfluor, Inc.
510(k) numberK884707
Submission
- Device name
- Fiagen Digoxin Time-Resolved Fluoroimmunoassay Kit
- Applicant
- Cyberfluor, Inc.
Ontario M5t 1x4, CA - Received
- November 9, 1988
- Decision date
- January 17, 1989
- 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 |
| 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 |
| K801413 | Amerlex Digoxin Ria KitLCS · Traditional | Amersham Corp. | 07/08/1980SE |
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| K904539 | Flagen TM Free T4CEC · Traditional | 11/30/1990SE |
| K900621 | Fiagen(Tm) Hlh.SCEP · Traditional | 03/01/1990SE |
| K895186 | Fiagen T3 Uptake Catalogue #101-402KHQ · Traditional | 11/08/1989SE |
| K895396 | Cyberfluor Fiagen TSHJLW · Traditional | 10/31/1989SE |
| K884708 | Fiagen HFSH Time-Resolved Fluoroimmunoassay KitCGJ · Traditional | 01/17/1989SE |
| K884201 | Fiagen TBG Time-Resolved Fluoroimmunoassay KitCEE · Traditional | 12/14/1988SE |
| K883182 | Fiagen Rubella IggLFX · Traditional | 10/31/1988SE |
| K882823 | Fiagen HGH Fluoroimmunoassay KitCFL · Traditional | 08/30/1988SE |
Questions and answers
When was Fiagen Digoxin Time-Resolved Fluoroimmunoassay Kit cleared by the FDA?
Fiagen Digoxin Time-Resolved Fluoroimmunoassay Kit (K884707) received a 510(k) decision of Substantially Equivalent on January 17, 1989, 69 days after the submission was received.
What is the product code of K884707?
The FDA product code is LCS – Radioimmunoassay, Digoxin (125-I), a Class II (moderate risk) device regulated under 21 CFR 862.3320.