The following data is part of a premarket notification filed by Windsor Laboratories, Inc. with the FDA for Phenytoin (fpia) Calibrator Kit.
| Device ID | K861770 |
| 510k Number | K861770 |
| Device Name: | PHENYTOIN (FPIA) CALIBRATOR KIT |
| Classification | Calibrator, Primary |
| Applicant | WINDSOR LABORATORIES, INC. P.O. BOX 475487 Garland, TX 75047 |
| Contact | Guy W Rucker |
| Correspondent | Guy W Rucker WINDSOR LABORATORIES, INC. P.O. BOX 475487 Garland, TX 75047 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-07 |
| Decision Date | 1986-06-25 |