The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Accustain(tm) - Automated Wright Giemsa Stain Set.
| Device ID | K890674 |
| 510k Number | K890674 |
| Device Name: | ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET |
| Classification | Wright's Stain |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Takes, Phd |
| Correspondent | Takes, Phd SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | IAF |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-09 |
| Decision Date | 1989-02-24 |