Technicon Star System
FDA 510(k) K791549 · Technicon Instruments Corp.
510(k) numberK791549
Submission
- Device name
- Technicon Star System
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- August 13, 1979
- Decision date
- September 27, 1979
- 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 |
|---|---|---|---|
| K902861 | Ciba Corning Acs Digoxin ImmunoassayDON · Traditional | Ciba Corning Diagnostics Corp. | 09/10/1990SE |
| 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 |
| 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 |
|---|---|---|
| K914888 | Technicon Chem 1(TM) Syst (GEN2 Syst)CIX · Traditional | 11/27/1991SE |
| K914511 | Technicon Axon(Tm) System Methods Anyalye HDL CholLBS · Traditional | 11/27/1991SE |
| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | 11/22/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
| K912413 | Chem-Link Data Base ManagerJJQ · Traditional | 07/01/1991SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Technicon Star System cleared by the FDA?
Technicon Star System (K791549) received a 510(k) decision of Substantially Equivalent on September 27, 1979, 45 days after the submission was received.
What is the product code of K791549?
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.