I-125 LABELED DIGOXIN
FDA 510(k) clearance K803047 · decided 1980-12-22
Clearance details
- K-number
- K803047
- Device name
- I-125 LABELED DIGOXIN
- Applicant
- Pcl-Ria, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-01
- Decision date
- 1980-12-22
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- LCS
- 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 |
|---|---|---|
| DIGOXIN COATED TUBE RIA (K922353) | Monobind | 1992-08-24 |
| QMS - DIGOXIN (K913562) | Seradyn, Inc. | 1991-08-30 |
| INNOFLUOR DIGOXIN REAGENT SET (K895828) | Innotron of Oregon, Inc. | 1989-10-30 |
| FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (K884707) | Cyberfluor, Inc. | 1989-01-17 |
| IMMPULSE DIGOXIN ASSAY REAGENTS (K874748) | Sclavo, Inc. | 1988-02-19 |
| DART DIGOXIN ASSAY (K864802) | Coulter Electronics, Inc. | 1987-02-12 |
| TDX DIGOXIN (K820154) | Abbott Laboratories | 1982-02-05 |
| ULTRA-DIG (K812749) | Antibodies, Inc. | 1981-10-19 |
| DIGOXIN EIA KIT (K801490) | M.A. Bioproducts | 1980-07-14 |
| AMERLEX DIGOXIN RIA KIT (K801413) | Amersham Corp. | 1980-07-08 |
| DIGOXIN RADIOIMMUNOASSAY KIT (K801202) | Technia Diagnostics , Ltd. | 1980-06-20 |
| DIGOXIN CLASP RIA KIT (K800997) | E. R. Squibb & Sons, Inc. | 1980-05-08 |
Recalls involving this device
No recalls on record reference this clearance.