PHENOBARBITAL TEST SYSTEM
FDA 510(k) clearance K860365 · decided 1986-03-17
Clearance details
- K-number
- K860365
- Device name
- PHENOBARBITAL TEST SYSTEM
- Applicant
- Allied Instrumentation Laboratory
- Decision
- Substantially Equivalent
- Date received
- 1986-02-03
- Decision date
- 1986-03-17
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- DLZ
- Device class
- 2
- Regulation number
- 862.3660
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Lexington, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.