510(k) K864449
- Device
- DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT
- Applicant
- CANADIAN BIOCLINICAL, LTD.
- 510(k) number
- K864449
- Product code
- DPO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-02-02
- Date received
- 1986-11-12
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DR. J CLAPP
- Address
- 81 Finchdene Sq., Scarborough Ontario Mix 1b4 CA
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DPO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K914833 | IMMULITE DIGOXIN | Cirrus Diagnostics, Inc. | 1991-11-22 |
| K905719 | ECLIPSE ICA DIGOXIN | Biotope, Inc. | 1991-01-17 |
| K833842 | RIA COAT DIGOXIN | Immuno Assay Corp. | 1984-01-17 |
| K832163 | SOPHEIA DIGOXIN EIA KIT | Diagnostic Products Corp. | 1983-08-12 |
| K830962 | IMMUCHEM COVALENT-COAT RIA KIT | Immuchem Corp. | 1983-05-04 |
| K811932 | COAT-A-COUNT DIGOXIN RIA | Diagnostic Products Corp. | 1981-07-23 |
| K811776 | KALLESTAD QUANTICOAT 125 DIGOXIN | Kallestad Laboratories, Inc. | 1981-07-10 |
| K800205 | RIA PHASE DIGOXIN | Boehringer Mannheim Corp. | 1980-03-19 |
| K791325 | AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM | Micromedic Systems | 1979-08-16 |
| K791355 | VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT | Ventrex Laboratories, Inc. | 1979-08-10 |
| K771638 | IGOXIN SOLID PHASE RIA | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-10-07 |
| K770365 | RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO | Travenol Laboratories, S.A. | 1977-02-24 |
| K770069 | DIGOXIN CLASP TM RIA KIT | E. R. Squibb & Sons, Inc. | 1977-01-18 |
Legacy Summary#
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FDA Review#
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