The following data is part of a premarket notification filed by Windsor Laboratories, Inc. with the FDA for Carbamazepine Fpia Fluores. Polariza. Immunoassay.
Device ID | K873282 |
510k Number | K873282 |
Device Name: | CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY |
Classification | Enzyme Immunoassay, Carbamazepine |
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 | KLT |
CFR Regulation Number | 862.3645 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-17 |
Decision Date | 1987-09-22 |