STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
FDA 510(k) clearance K934003 · decided 1994-11-22
Clearance details
- K-number
- K934003
- Device name
- STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
- Applicant
- Baxter Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-17
- Decision date
- 1994-11-22
- Days to decision
- 462 days
- Clearance type
- Traditional
- Product code
- DKA
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mcgaw Park, 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 |
|---|---|---|
| CBR-DIGOXIN ANTISERUM (K780498) | Clinical Bioresearch | 1978-04-05 |
| RABBIT ANTIBODY TO DIGOXIN (K780316) | Pcl-Ria, Inc. | 1978-03-17 |
Recalls involving this device
No recalls on record reference this clearance.