The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Coated Tube High Sensitivity Tsh 100 Uiu/ml Stan..
| Device ID | K895648 |
| 510k Number | K895648 |
| Device Name: | COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN. |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-20 |
| Decision Date | 1990-01-18 |