IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
FDA 510(k) clearance K865102 · decided 1987-01-13
Clearance details
- K-number
- K865102
- Device name
- IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS
- Applicant
- Sclavo, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-24
- Decision date
- 1987-01-13
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- LES
- Device class
- 2
- Regulation number
- 862.3350
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Sunnyvale, CA, 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 |
|---|---|---|
| SYVA ADVANCE EMIT PHENYTOIN ASSAY (K844990) | Syva Co. | 1985-01-23 |
| STRATUS PHENYTOIN FLUOROMETRIC ENZYME (K831154) | American Dade | 1983-05-16 |
| SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY (K820187) | Syva Co. | 1982-02-12 |
| PHENYTOIN FLUORESCENT IMMUNOASSAY (K813538) | American Diagnostic Corp. | 1981-12-31 |
| AMES TDA TM PHENYTOIN TEST (K811025) | Miles Laboratories, Inc. | 1981-04-29 |
| AMES TDA TM PHENYTOIN TEST (K801736) | Miles Laboratories, Inc. | 1980-08-20 |
Recalls involving this device
No recalls on record reference this clearance.