Immulite Digoxin
FDA 510(k) K914833 · Cirrus Diagnostics, Inc.
510(k) numberK914833
Submission
- Device name
- Immulite Digoxin
- Applicant
- Cirrus Diagnostics, Inc.
Chester, NJ, US - Received
- October 25, 1991
- Decision date
- November 22, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPO – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DPO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K905719 | Eclipse Ica DigoxinDPO · Traditional | Biotope, Inc. | 01/17/1991SE |
| K864449 | Digoxin/Ria Kit Coated Tube Radioimmunoassay KitDPO · Traditional | Canadian Bioclinical, Ltd. | 02/02/1987SE |
| K833842 | Ria Coat DigoxinDPO · Traditional | Immuno Assay Corp. | 01/17/1984SE |
| K832163 | Sopheia Digoxin Eia KitDPO · Traditional | Diagnostic Products Corp. | 08/12/1983SE |
| K830962 | Immuchem Covalent-Coat Ria KitDPO · Traditional | Immuchem Corp. | 05/04/1983SE |
| K811932 | Coat-A-Count Digoxin RiaDPO · Traditional | Diagnostic Products Corp. | 07/23/1981SE |
| K811776 | Kallestad Quanticoat 125 DigoxinDPO · Traditional | Kallestad Laboratories, Inc. | 07/10/1981SE |
| K800205 | Ria Phase DigoxinDPO · Traditional | Boehringer Mannheim Corp. | 03/19/1980SE |
| K791325 | Autopak 12 Digoxin Test Delivery SystemDPO · Traditional | Micromedic Systems | 08/16/1979SE |
| K791355 | Ventre/Sep Digoxin Radioimmunoassay KitDPO · Traditional | Ventrex Laboratories, Inc. | 08/10/1979SE |
More from Ventrex Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921704 | Immulite(R) FSHCGJ · Traditional | 06/09/1992SE |
| K920411 | Immulite HLHCEP · Traditional | 03/11/1992SE |
| K911796 | Immulite(Tm) HCGDHA · Traditional | 06/20/1991SE |
| K910677 | Immulite(Tm) T-UptakeCEE · Traditional | 04/29/1991SE |
| K910261 | Immulite(Tm) Total T4KLI · Traditional | 04/16/1991SE |
| K905648 | CRP Lipid Reagent Test PackCHH · Traditional | 03/06/1991SE |
| K905214 | Immulite (TM) Total T3CDP · Traditional | 02/01/1991SE |
| K905769 | Immulite Hs-TshJLW · Traditional | 01/31/1991SE |
| K905215 | Immulite (TM) Automated Immunoassay AnalyzerJJQ · Traditional | 01/11/1991SE |
Questions and answers
When was Immulite Digoxin cleared by the FDA?
Immulite Digoxin (K914833) received a 510(k) decision of Substantially Equivalent on November 22, 1991, 28 days after the submission was received.
What is the product code of K914833?
The FDA product code is DPO – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.