DIGI TROL TM-RX & DIGI TROL TM-TX
FDA 510(k) clearance K770411 · decided 1977-03-16
Clearance details
- K-number
- K770411
- Device name
- DIGI TROL TM-RX & DIGI TROL TM-TX
- Applicant
- Nuclear Medical Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-03-04
- Decision date
- 1977-03-16
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- DMP
- Device class
- 1
- Regulation number
- 862.3280
- 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 |
|---|---|---|
| ELECSYS CALLCHECK DIGOXIN (K973973) | Boehringer Mannheim Corp. | 1997-11-04 |
| TOX PERFECT A TUBE (K953393) | Chimera Research & Chemical, Inc. | 1995-10-06 |
| DIGOXIN STANDARDS IN HUMAN SERUM (K780889) | Pcl-Ria, Inc. | 1978-08-14 |
Recalls involving this device
No recalls on record reference this clearance.