The following data is part of a premarket notification filed by Hycor Biomedical, Inc. with the FDA for Ventrex Coated Tube High Sensit. Tsh Radioimmunoas.
| Device ID | K920856 |
| 510k Number | K920856 |
| Device Name: | VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | HYCOR BIOMEDICAL, INC. 217 READ ST. P.O. BOX 9731 Portland, MA 04104 |
| Contact | Jan L Trott |
| Correspondent | Jan L Trott HYCOR BIOMEDICAL, INC. 217 READ ST. P.O. BOX 9731 Portland, MA 04104 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-18 |
| Decision Date | 1992-03-26 |