The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrex Coated Tube High Sensitivity Tsh.
| Device ID | K885157 |
| 510k Number | K885157 |
| Device Name: | VENTREX COATED TUBE HIGH SENSITIVITY TSH |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04103 |
| Contact | James W Champlin |
| Correspondent | James W Champlin VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04103 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-13 |
| Decision Date | 1989-02-10 |