The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Infinity Hba Kit, Models 537-a, 537-b.
| Device ID | K012410 |
| 510k Number | K012410 |
| Device Name: | INFINITY HBA KIT, MODELS 537-A, 537-B |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | William R Gilbert Ii |
| Correspondent | William R Gilbert Ii SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-30 |
| Decision Date | 2001-10-26 |
| Summary: | summary |