510(k) K800090
K800090 is an FDA 510(k) premarket notification submitted by Bio-Rad for the device "FLUOROMATIC PHENOLBARBITAL FIA". The FDA issued a decision of Substantially Equivalent on January 23, 1980. The device falls under product code DKP (Radioimmunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Bio-Rad has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1980
- Date Received
- January 14, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Phenobarbital
- Device Class
- Class II
- Regulation Number
- 862.3660
- Review Panel
- TX
- Submission Type