IN VITRO DIGOXIN RIA TEST
FDA 510(k) clearance K772110 · decided 1977-11-22
Clearance details
- K-number
- K772110
- Device name
- IN VITRO DIGOXIN RIA TEST
- Applicant
- Clinical Assays, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-11-07
- Decision date
- 1977-11-22
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- DNL
- 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 |
|---|---|---|
| DIG RADIOIMMUNOASSAY TEST SYSTEM (K852343) | M Nobird, Inc. | 1985-07-09 |
| TIPSEP DIGOXIN RIA (K852291) | Nuclear Diagnostics, Inc. | 1985-06-25 |
| DIGOXIN (RIA) KIT (K811212) | Immuno Assay Corp. | 1981-05-21 |
| DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT (K810966) | E. R. Squibb & Sons, Inc. | 1981-04-21 |
| DIGOXIN RADIOIMMUNOASSAY KIT (K802841) | American Diagnostic Corp. | 1980-12-18 |
| TEST SET, 125 I-DIGOXIN (K781834) | Wien Laboratories, Inc. | 1979-01-03 |
| RIANEN ASSAY SYSTEM, 125I KIT (K781495) | New England Nuclear | 1978-09-14 |
Recalls involving this device
No recalls on record reference this clearance.