510(k) K910355
K910355 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL PHENOBARBITAL ASSAY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 3, 1991. 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
- April 3, 1991
- Date Received
- January 29, 1991
- 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