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 |