TECHNICON RA-PHENOBARBITAL
FDA 510(k) clearance K884419 · decided 1988-11-22
Clearance details
- K-number
- K884419
- Device name
- TECHNICON RA-PHENOBARBITAL
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-20
- Decision date
- 1988-11-22
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- DLZ
- Device class
- 2
- Regulation number
- 862.3660
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Tarrytown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.