The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Stratus Digoxin Flourometric Enzyme Immunoassay.
| Device ID | K934003 |
| 510k Number | K934003 |
| Device Name: | STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY |
| Classification | Antiserum, Digoxin |
| Applicant | BAXTER DIAGNOSTICS, INC. SCIENTIFIC PRODUCTS DIV. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Ronald H Lentsch |
| Correspondent | Ronald H Lentsch BAXTER DIAGNOSTICS, INC. SCIENTIFIC PRODUCTS DIV. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | DKA |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-17 |
| Decision Date | 1994-11-22 |