The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Theophylline Fpia Reagent Set And Calibrators.
| Device ID | K942192 |
| 510k Number | K942192 |
| Device Name: | THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS |
| Classification | Fluorescent Immunoassay, Theophylline |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Contact | Barry D Robins |
| Correspondent | Barry D Robins SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St.louis, MO 63103 |
| Product Code | LER |
| CFR Regulation Number | 862.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-04 |
| Decision Date | 1994-07-13 |