OPUS DIGITOXIN
FDA 510(k) clearance K935229 · decided 1993-12-22
Clearance details
- K-number
- K935229
- Device name
- OPUS DIGITOXIN
- Applicant
- Pb Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-11-01
- Decision date
- 1993-12-22
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- DPG
- Device class
- 2
- Regulation number
- 862.3300
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Westwood, MA, 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 |
|---|---|---|
| COAT-A-COUNT DIGITOXIN RIA KIT (K812129) | Diagnostic Products Corp. | 1981-08-13 |
| RIALYZE DIGOXIN (K780075) | Miles Laboratories, Inc. | 1978-02-28 |
Recalls involving this device
No recalls on record reference this clearance.