510(k) K771877
K771877 is an FDA 510(k) premarket notification submitted by Antibodies, Inc. for the device "DIGOXIN RIA KIT". The FDA issued a decision of Substantially Equivalent on October 21, 1977. The device falls under product code DNJ (Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.), a Class II device regulated under 21 CFR 862.3320. Antibodies, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1977
- Date Received
- October 4, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
- Device Class
- Class II
- Regulation Number
- 862.3320
- Review Panel
- TX
- Submission Type