510(k) K780316
K780316 is an FDA 510(k) premarket notification submitted by Pcl-Ria, Inc. for the device "RABBIT ANTIBODY TO DIGOXIN". The FDA issued a decision of Substantially Equivalent on March 17, 1978. The device falls under product code DKA (Antiserum, Digoxin), a Class II device regulated under 21 CFR 862.3320. Pcl-Ria, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1978
- Date Received
- February 24, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiserum, Digoxin
- Device Class
- Class II
- Regulation Number
- 862.3320
- Review Panel
- TX
- Submission Type