510(k) K943981
K943981 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST PHENOBARBITAL CALIBRATORS". The FDA issued a decision of Substantially Equivalent on January 18, 1995. The device falls under product code DLZ (Enzyme Immunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1995
- Date Received
- June 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Phenobarbital
- Device Class
- Class II
- Regulation Number
- 862.3660
- Review Panel
- TX
- Submission Type