510(k) K940569
K940569 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET". The FDA issued a decision of Substantially Equivalent on Jul 13, 1994. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 13, 1994
- Date Received
- Feb 8, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Enzyme Immunoassay, Digoxin
- Device Class
- Class II
- Regulation Number
- 862.3320
- Review Panel
- TX
- Submission Type
- 510(k)