The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Electrode, Ion Specific.
| Device ID | K915675 |
| 510k Number | K915675 |
| Device Name: | ELECTRODE, ION SPECIFIC |
| Classification | Electrode, Ion Specific, Calcium |
| Applicant | ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746 |
| Contact | Brian Young |
| Correspondent | Brian Young ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746 |
| Product Code | JFP |
| CFR Regulation Number | 862.1145 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-19 |
| Decision Date | 1992-04-29 |