The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Glycohemoglobin Procedure.
| Device ID | K862556 |
| 510k Number | K862556 |
| Device Name: | SANDARE GLYCOHEMOGLOBIN PROCEDURE |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | SANDARE CHEMICAL CO., INC. P.O. BOX 3028 Desoto, TX 75115 |
| Contact | James L Sanders |
| Correspondent | James L Sanders SANDARE CHEMICAL CO., INC. P.O. BOX 3028 Desoto, TX 75115 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-03 |
| Decision Date | 1986-08-08 |