The following data is part of a premarket notification filed by Amdev, Inc. with the FDA for Lytening 6 Sodium/potassium/ionized Calcium Analyz.
| Device ID | K884731 |
| 510k Number | K884731 |
| Device Name: | LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ |
| Classification | Electrode, Ion Specific, Calcium |
| Applicant | AMDEV, INC. 35 CHERRY HILL DR. Danvers, MA 01923 -2565 |
| Contact | Connie J Hertel |
| Correspondent | Connie J Hertel AMDEV, INC. 35 CHERRY HILL DR. Danvers, MA 01923 -2565 |
| Product Code | JFP |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-10 |
| Decision Date | 1989-02-03 |