The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Ames Dca 2000 Hemoglobin Alc Controls.
| Device ID | K940971 |
| 510k Number | K940971 |
| Device Name: | AMES DCA 2000 HEMOGLOBIN ALC CONTROLS |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | HERAEUS KULZER, INC. 1127 MYRTLE ST. Elkhart, IN 46514 |
| Contact | Rosanne M Savol |
| Correspondent | Rosanne M Savol HERAEUS KULZER, INC. 1127 MYRTLE ST. Elkhart, IN 46514 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-02 |
| Decision Date | 1994-07-19 |