The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easylyte Quality Control Kit, Models 2814, 2815, 2816.
| Device ID | K990971 |
| 510k Number | K990971 |
| Device Name: | EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 |
| Classification | Electrolyte Controls (assayed And Unassayed) |
| Applicant | MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Contact | Photios Makris |
| Correspondent | Photios Makris MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Product Code | JJR |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-23 |
| Decision Date | 1999-04-27 |