510(k) K830479
K830479 is an FDA 510(k) premarket notification submitted by Hoffmann-La Roche, Inc. for the device "ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE". The FDA issued a decision of Substantially Equivalent on March 10, 1983. The device falls under product code DKN (Radioimmunoassay, Barbiturate), a Class II device regulated under 21 CFR 862.3150. Hoffmann-La Roche, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1983
- Date Received
- February 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Barbiturate
- Device Class
- Class II
- Regulation Number
- 862.3150
- Review Panel
- TX
- Submission Type