510(k) K772111
K772111 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "IN VITRO PHENOBARBITAL RIA TEST". The FDA issued a decision of Substantially Equivalent on November 28, 1977. The device falls under product code DKP (Radioimmunoassay, Phenobarbital), a Class II device regulated under 21 CFR 862.3660. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 28, 1977
- Date Received
- November 7, 1977
- 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