RIALYZE DIGOXIN
FDA 510(k) clearance K780075 · decided 1978-02-28
Clearance details
- K-number
- K780075
- Device name
- RIALYZE DIGOXIN
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-01-16
- Decision date
- 1978-02-28
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- DPG
- Device class
- 2
- Regulation number
- 862.3300
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Miles Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OPUS DIGITOXIN (K935229) | Pb Diagnostic Systems, Inc. | 1993-12-22 |
| COAT-A-COUNT DIGITOXIN RIA KIT (K812129) | Diagnostic Products Corp. | 1981-08-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |