SOPHEIA DIGOXIN EIA KIT
FDA 510(k) clearance K832163 · decided 1983-08-12
Clearance details
- K-number
- K832163
- Device name
- SOPHEIA DIGOXIN EIA KIT
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-07-05
- Decision date
- 1983-08-12
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- DPO
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMMULITE DIGOXIN (K914833) | Cirrus Diagnostics, Inc. | 1991-11-22 |
| ECLIPSE ICA DIGOXIN (K905719) | Biotope, Inc. | 1991-01-17 |
| DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT (K864449) | Canadian Bioclinical, Ltd. | 1987-02-02 |
| RIA COAT DIGOXIN (K833842) | Immuno Assay Corp. | 1984-01-17 |
| IMMUCHEM COVALENT-COAT RIA KIT (K830962) | Immuchem Corp. | 1983-05-04 |
| COAT-A-COUNT DIGOXIN RIA (K811932) | Diagnostic Products Corp. | 1981-07-23 |
| KALLESTAD QUANTICOAT 125 DIGOXIN (K811776) | Kallestad Laboratories, Inc. | 1981-07-10 |
| RIA PHASE DIGOXIN (K800205) | Boehringer Mannheim Corp. | 1980-03-19 |
| AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM (K791325) | Micromedic Systems | 1979-08-16 |
| VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT (K791355) | Ventrex Laboratories, Inc. | 1979-08-10 |
| IGOXIN SOLID PHASE RIA (K771638) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-10-07 |
| RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO (K770365) | Travenol Laboratories, S.A. | 1977-02-24 |
Recalls involving this device
No recalls on record reference this clearance.