The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Accucolor High Calibrator (a3089).
| Device ID | K973274 |
| 510k Number | K973274 |
| Device Name: | ACCUCOLOR HIGH CALIBRATOR (A3089) |
| Classification | Plasma, Control, Normal |
| 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 | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-10-31 |
| Summary: | summary |