510(k) K791549
K791549 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "TECHNICON STAR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 27, 1979. The device falls under product code DON (Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.), a Class II device regulated under 21 CFR 862.3320. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1979
- Date Received
- August 13, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
- Device Class
- Class II
- Regulation Number
- 862.3320
- Review Panel
- TX
- Submission Type