The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Normal Glycohemoglobin Control (a1c Hgb).
| Device ID | K902455 |
| 510k Number | K902455 |
| Device Name: | ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Contact | W Bonderman |
| Correspondent | W Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-04 |
| Decision Date | 1990-07-24 |