510(k) K791549
- Device
- Technicon Star System
- Applicant
- TECHNICON INSTRUMENTS CORP.
- 510(k) number
- K791549
- Product code
- DON
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-09-27
- Date received
- 1979-08-13
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DON#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K902861 | CIBA CORNING ACS DIGOXIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1990-09-10 |
| K881679 | CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1988-07-08 |
| K840461 | MAGIC 125I DIGOXIN RADIOIMMUNOASSAY | Corning Medical & Scientific | 1984-03-23 |
| K830533 | PHASE II DIGOXIN RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | 1983-04-05 |
| K822053 | ZETAPHASE-DIG | Biological & Diagnostic Products | 1982-07-27 |
| K821000 | ENZYMUNE-TEST DIGOXIN | Icl Scientific | 1982-04-26 |
| K810296 | DIGOXIN RIA ASSAY | Ria Diagnostics | 1981-02-19 |
| K803075 | DIGOXIN RIABEAD DIAGNOSTIC KIT | Abbott Laboratories | 1980-12-22 |
| K781660 | RIA, DIGOXIN | E. R. Squibb & Sons, Inc. | 1978-10-24 |
| K780475 | DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT | Burroughs Wellcome Co. | 1978-04-24 |
| K780207 | LIQUISOL DIGOXIN RIA TEST KIT | Damon Corp. | 1978-02-23 |
| K772422 | QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA | Bio-Rad | 1978-02-13 |
| K772098 | DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-12-20 |
| K771255 | CEBTRIA DIGOXIN RIA | Union Carbide Corp. | 1977-08-25 |
| K770269 | CAMMADISK DIGOXIN | Burroughs Wellcome Co. | 1977-03-16 |