ENDAB PHENOBARBITAL
FDA 510(k) clearance K852995 · decided 1985-08-12
Clearance details
- K-number
- K852995
- Device name
- ENDAB PHENOBARBITAL
- Applicant
- Immunotech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-15
- Decision date
- 1985-08-12
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DLZ
- Device class
- 2
- Regulation number
- 862.3660
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.