DIGOXIN KIT
FDA 510(k) clearance K823014 · decided 1982-11-01
Clearance details
- K-number
- K823014
- Device name
- DIGOXIN KIT
- Applicant
- Pcl-Ria, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-10-13
- Decision date
- 1982-11-01
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- DPB
- 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 |
|---|---|---|
| OPTIMATE DIGOXIN TEST (K853021) | Miles Laboratories, Inc. | 1985-08-07 |
| 125I DIGOXIN RADIOIMMUNOASSAY KIT (K821811) | Cambridge Medical Technology | 1982-07-02 |
| DIGOXIN RADIOIMMUNOASSAY (K820274) | American Diagnostic Corp. | 1982-02-23 |
| DIGOXIN RADIOIMMUNOASSAY SYSTEM (K792153) | Radioimmunoassay, Inc. | 1979-11-13 |
| RIA, DIGNXIN-125-I (K790602) | Endocrine-Metabolic Center | 1979-07-30 |
| RIA TEST KIT, CENTRIA DIGOXIN (K790540) | Ventrex Laboratories, Inc. | 1979-04-23 |
| 125I DIGOXIN TEST SET (K772306) | Wien Laboratories, Inc. | 1977-12-22 |
| 125 I DIGOXIN RIA KIT (K771525) | Diagnostic Products Corp. | 1977-10-14 |
| DIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAY (K760883) | Nuclear Medical Laboratories, Inc. | 1976-11-19 |
Recalls involving this device
No recalls on record reference this clearance.