The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Stratus(r) Total Thyroxine(t4) Fluor Enzyme Immuno.
| Device ID | K933426 |
| 510k Number | K933426 |
| Device Name: | STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO |
| Classification | Radioimmunoassay, Total Thyroxine |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Ronald H Lentsch |
| Correspondent | Ronald H Lentsch BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | CDX |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-13 |
| Decision Date | 1993-08-26 |