ANTICONVULSANTS III CALIBRATOR KIT
FDA 510(k) clearance K780733 · decided 1978-06-22
Clearance details
- K-number
- K780733
- Device name
- ANTICONVULSANTS III CALIBRATOR KIT
- Applicant
- Vitek Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-05-02
- Decision date
- 1978-06-22
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- DKH
- Device class
- 2
- Regulation number
- 862.3350
- 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 |
|---|---|---|
| DUPONT PREP APPLI. FOR PHENOBARBITAL, (K801276) | E.I. Dupont DE Nemours & Co., Inc. | 1980-06-20 |
Recalls involving this device
No recalls on record reference this clearance.