The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Ames Dca 2000tm Analyzer And Reagent System.
| Device ID | K911625 |
| 510k Number | K911625 |
| Device Name: | AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | HERAEUS KULZER, INC. 430 S. BEIGER ST. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
| Contact | Rosanne M Savol |
| Correspondent | Rosanne M Savol HERAEUS KULZER, INC. 430 S. BEIGER ST. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
| Product Code | LCP |
| CFR Regulation Number | 864.7470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-11 |
| Decision Date | 1991-09-05 |