The following data is part of a premarket notification filed by Medica Corp. with the FDA for Easy Lyte Calcium Analyzer.
| Device ID | K943091 |
| 510k Number | K943091 |
| Device Name: | EASY LYTE CALCIUM ANALYZER |
| Classification | Electrode, Ion Specific, Calcium |
| Applicant | MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Contact | Photios Makris, Ph.d. |
| Correspondent | Photios Makris, Ph.d. MEDICA CORP. 14 DEANGELO DR. Bedford, MA 01730 |
| Product Code | JFP |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CHL |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-28 |
| Decision Date | 1995-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00386100003296 | K943091 | 000 |
| 00386100003159 | K943091 | 000 |
| 00386100003142 | K943091 | 000 |
| 00386100003135 | K943091 | 000 |
| 00386100003111 | K943091 | 000 |
| 00386100003067 | K943091 | 000 |
| 00386100002893 | K943091 | 000 |