510(k) K861195
K861195 is an FDA 510(k) premarket notification submitted by Lkb Instruments, Inc. for the device "DELFIA DIGOXIN". The FDA issued a decision of Substantially Equivalent on July 11, 1986. The device falls under product code KXT (Enzyme Immunoassay, Digoxin), a Class II device regulated under 21 CFR 862.3320. Lkb Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1986
- Date Received
- March 31, 1986
- 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