The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Dca 2000 System For Hemoglobin A1c.
| Device ID | K951361 |
| 510k Number | K951361 |
| Device Name: | DCA 2000 SYSTEM FOR HEMOGLOBIN A1C |
| Classification | Assay, Glycosylated Hemoglobin |
| Applicant | HERAEUS KULZER, INC. P.O. BOX 2004 Mishawaka, IN 46546 -2004 |
| Contact | Rosanne M Savol |
| Correspondent | Rosanne M Savol HERAEUS KULZER, INC. 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 | 1995-03-27 |
| Decision Date | 1995-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414532806 | K951361 | 000 |
| 00630414171142 | K951361 | 000 |