RIA, DIGOXIN
FDA 510(k) clearance K781660 · decided 1978-10-24
Clearance details
- K-number
- K781660
- Device name
- RIA, DIGOXIN
- Applicant
- E. R. Squibb & Sons, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-09-28
- Decision date
- 1978-10-24
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- DON
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- New York, NY, 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 |
|---|---|---|
| CIBA CORNING ACS DIGOXIN IMMUNOASSAY (K902861) | Ciba Corning Diagnostics Corp. | 1990-09-10 |
| CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY (K881679) | Ciba Corning Diagnostics Corp. | 1988-07-08 |
| MAGIC 125I DIGOXIN RADIOIMMUNOASSAY (K840461) | Corning Medical & Scientific | 1984-03-23 |
| PHASE II DIGOXIN RADIOIMMUNOASSAY KIT (K830533) | Medical & Scientific Designs, Inc. | 1983-04-05 |
| ZETAPHASE-DIG (K822053) | Biological & Diagnostic Products | 1982-07-27 |
| ENZYMUNE-TEST DIGOXIN (K821000) | Icl Scientific | 1982-04-26 |
| DIGOXIN RIA ASSAY (K810296) | Ria Diagnostics | 1981-02-19 |
| DIGOXIN RIABEAD DIAGNOSTIC KIT (K803075) | Abbott Laboratories | 1980-12-22 |
| TECHNICON STAR SYSTEM (K791549) | Technicon Instruments Corp. | 1979-09-27 |
| DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT (K780475) | Burroughs Wellcome Co. | 1978-04-24 |
| LIQUISOL DIGOXIN RIA TEST KIT (K780207) | Damon Corp. | 1978-02-23 |
| QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA (K772422) | Bio-Rad | 1978-02-13 |
Recalls involving this device
No recalls on record reference this clearance.