The following data is part of a premarket notification filed by Windsor Laboratories, Inc. with the FDA for Digoxin Fpia Fluorescence Polarization Immunoassay.
| Device ID | K864333 |
| 510k Number | K864333 |
| Device Name: | DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY |
| Classification | Enzyme Immunoassay, Digoxin |
| Applicant | WINDSOR LABORATORIES, INC. P.O. BOX 475487 Garland, TX 75047 |
| Contact | Guy Rucker |
| Correspondent | Guy Rucker WINDSOR LABORATORIES, INC. P.O. BOX 475487 Garland, TX 75047 |
| Product Code | KXT |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-04 |
| Decision Date | 1987-01-05 |