The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrex Coated Tube Intact Pth.
| Device ID | K913434 |
| 510k Number | K913434 |
| Device Name: | VENTREX COATED TUBE INTACT PTH |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04103 |
| Contact | H. W Founds |
| Correspondent | H. W Founds VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04103 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-01 |
| Decision Date | 1991-10-25 |