The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Glucometer Elite Low Control.
| Device ID | K940577 |
| 510k Number | K940577 |
| Device Name: | GLUCOMETER ELITE LOW CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-08 |
| Decision Date | 1994-06-13 |