The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Vancomycin Fpia Reagent Set.
| Device ID | K955716 |
| 510k Number | K955716 |
| Device Name: | VANCOMYCIN FPIA REAGENT SET |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William R Gilbert |
| Correspondent | William R Gilbert SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-15 |
| Decision Date | 1996-02-16 |