The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Procedure No. 465 For Deter. Of Fructosamine.
| Device ID | K884184 |
| 510k Number | K884184 |
| Device Name: | SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Leo Bressler |
| Correspondent | Leo Bressler SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-04 |
| Decision Date | 1989-03-28 |