The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Fast Hemoglobin Control-lyophilized.
| Device ID | K800794 |
| 510k Number | K800794 |
| Device Name: | FAST HEMOGLOBIN CONTROL-LYOPHILIZED |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ISOLAB, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-09 |
| Decision Date | 1980-04-29 |