DART PHENOBARBITAL ASSAY SYSTEM
FDA 510(k) clearance K864612 · decided 1987-01-13
Clearance details
- K-number
- K864612
- Device name
- DART PHENOBARBITAL ASSAY SYSTEM
- Applicant
- Coulter Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-24
- Decision date
- 1987-01-13
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- LFN
- Device class
- 2
- Regulation number
- 862.3660
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Hialeah, FL, 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 |
|---|---|---|
| QMS PHENOBARBITAL (K934388) | Seradyn, Inc. | 1994-02-25 |
| DUPONT PHENOBARBITAL ASSAY (K860304) | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 |
| DUPONT PHENOBARBITAL CALIBRATOR (K860303) | E.I. Dupont DE Nemours & Co., Inc. | 1986-02-28 |
| IPA FOR DETECTION OF PHENOBARBITAL (K821543) | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 |
Recalls involving this device
No recalls on record reference this clearance.