The following data is part of a premarket notification filed by Biostride Diagnostics, Inc. with the FDA for Biostride Free T4 Eia Test Kit.
| Device ID | K981243 |
| 510k Number | K981243 |
| Device Name: | BIOSTRIDE FREE T4 EIA TEST KIT |
| Classification | Radioimmunoassay, Free Thyroxine |
| Applicant | BIOSTRIDE DIAGNOSTICS, INC. 1206 SESAME DR. Sunnyvale, CA 94087 |
| Contact | Janis Freestone |
| Correspondent | Janis Freestone BIOSTRIDE DIAGNOSTICS, INC. 1206 SESAME DR. Sunnyvale, CA 94087 |
| Product Code | CEC |
| CFR Regulation Number | 862.1695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-06 |
| Decision Date | 1998-06-29 |
| Summary: | summary |