510(k) K831188
K831188 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "CONNECTOR TUBE". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code DOY (Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.), a Class II device regulated under 21 CFR 862.3320. Medrad, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1983
- Date Received
- April 12, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.
- Device Class
- Class II
- Regulation Number
- 862.3320
- Review Panel
- TX
- Submission Type