The following data is part of a premarket notification filed by Windsor Laboratories, Inc. with the FDA for (fpia) Assay Buffer.
Device ID | K871486 |
510k Number | K871486 |
Device Name: | (FPIA) ASSAY BUFFER |
Classification | Analyzer, Chemistry, Micro, For Clinical Use |
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 | JJF |
CFR Regulation Number | 862.2170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-15 |
Decision Date | 1987-05-08 |