510(k) K810477
K810477 is an FDA 510(k) premarket notification submitted by Diagnostic Corp. of America for the device "DCA DIGOX-SYN RIA TEST". The FDA issued a decision of Substantially Equivalent on March 11, 1981. The device falls under product code DOG (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol), a Class II device regulated under 21 CFR 862.3320. Diagnostic Corp. of America has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1981
- Date Received
- February 23, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol
- Device Class
- Class II
- Regulation Number
- 862.3320
- Review Panel
- TX
- Submission Type