FPR PHENYTOIN KIT
FDA 510(k) clearance K894527 · decided 1989-09-25
Clearance details
- K-number
- K894527
- Device name
- FPR PHENYTOIN KIT
- Applicant
- Colony Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-20
- Decision date
- 1989-09-25
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- DLP
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Washington, DC, 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 |
|---|---|---|
| KALLESTAD ANTISERA TO PHENYTOIN (K811775) | Kallestad Laboratories, Inc. | 1981-07-10 |
| FLUOROMATIC PHENYTOIN FIA (K792640) | Bio-Rad | 1980-01-11 |
| CENTRIA PHENYTOIN RIA TEST SET (K791896) | Ventrex Laboratories, Inc. | 1979-10-17 |
| PHENYTOIN RIA KIT (K770779) | Amersham Corp. | 1977-06-17 |
Recalls involving this device
No recalls on record reference this clearance.