The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Reticulocyte Stain.
| Device ID | K875310 |
| 510k Number | K875310 |
| Device Name: | RETICULOCYTE STAIN |
| Classification | Methylene Blue, Tissue 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 | KFC |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-02-09 |