The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Connector Tube.
| Device ID | K831188 |
| 510k Number | K831188 |
| Device Name: | CONNECTOR TUBE |
| Classification | Radioimmunoassay, Digoxin (3-h), Goat Antibody, 2nd Antibody Sep. |
| Applicant | MEDRAD, INC. 566 ALPHA DRIVE Pittsburgh, PA 15238 |
| Contact | Larry Kopyta |
| Correspondent | Larry Kopyta MEDRAD, INC. 566 ALPHA DRIVE Pittsburgh, PA 15238 |
| Product Code | DOY |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-12 |
| Decision Date | 1983-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40616258010128 | K831188 | 000 |
| 40616258021988 | K831188 | 000 |
| 40616258021971 | K831188 | 000 |