Ciba Corning Acs Digoxin Immunoassay
FDA 510(k) K902861 · Ciba Corning Diagnostics Corp.
510(k) numberK902861
Submission
- Device name
- Ciba Corning Acs Digoxin Immunoassay
- Applicant
- Ciba Corning Diagnostics Corp.
East Walpole, MA, US - Received
- June 28, 1990
- Decision date
- September 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DON – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3320
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DON
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881679 | Ciba Corning Magic Lite Digoxin ImmunoassayDON · Traditional | Ciba Corning Diagnostics Corp. | 07/08/1988SE |
| K840461 | Magic 125I Digoxin RadioimmunoassayDON · Traditional | Corning Medical & Scientific | 03/23/1984SE |
| K830533 | Phase II Digoxin Radioimmunoassay KitDON · Traditional | Medical & Scientific Designs, Inc. | 04/05/1983SE |
| K822053 | Zetaphase-DigDON · Traditional | Biological & Diagnostic Products | 07/27/1982SE |
| K821000 | Enzymune-Test DigoxinDON · Traditional | Icl Scientific | 04/26/1982SE |
| K810296 | Digoxin Ria AssayDON · Traditional | Ria Diagnostics | 02/19/1981SE |
| K803075 | Digoxin Riabead Diagnostic KitDON · Traditional | Abbott Laboratories | 12/22/1980SE |
| K791549 | Technicon Star SystemDON · Traditional | Technicon Instruments Corp. | 09/27/1979SE |
| K781660 | Ria, DigoxinDON · Traditional | E. R. Squibb & Sons, Inc. | 10/24/1978SE |
| K780475 | Dac-Cel Digoxin Radioimmunoassay KitDON · Traditional | Burroughs Wellcome Co. | 04/24/1978SE |
More from Burroughs Wellcome Co.
| 510(k) | Device | Decision |
|---|---|---|
| K962559 | Acs Cortisol ImmunoassayJFT · Traditional | 11/05/1996SE |
| K963251 | Ciba Corning ACS;180 DPD AssayJMM · Traditional | 10/15/1996SE |
| K961807 | Certain HCT Level a & Level B/Cvm HCT Levels 1,2,3, & 4GLK · Traditional | 07/26/1996SE |
| K961657 | Ciba Corning 400 SystemCHL · Traditional | 06/25/1996SE |
| K962021 | Ciba Corning 348 SystemCHL · Traditional | 06/24/1996SE |
| K962126 | Acs CKMB II ImmunoassayJHS · Traditional | 06/21/1996SE |
| K962041 | Acs LH2 ImmunoassayCEP · Traditional | 06/21/1996SE |
| K961510 | Acs FRT4 ImmunoassayJJX · Traditional | 06/17/1996SE |
| K960246 | Liquid Cardiac Marker 1,2,3 AssayedJJT · Traditional | 04/23/1996SE |
| K955873 | Acs Phenytoin AssayLGR · Traditional | 03/11/1996SE |
Questions and answers
When was Ciba Corning Acs Digoxin Immunoassay cleared by the FDA?
Ciba Corning Acs Digoxin Immunoassay (K902861) received a 510(k) decision of Substantially Equivalent on September 10, 1990, 74 days after the submission was received.
What is the product code of K902861?
The FDA product code is DON – Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep., a Class II (moderate risk) device regulated under 21 CFR 862.3320.