The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Cal 1 And Cal 2 Standards/standards For Il 501 Sodium/potassium Analyzer.
| Device ID | K935547 |
| 510k Number | K935547 |
| Device Name: | CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Contact | Brian J Young |
| Correspondent | Brian J Young ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-17 |
| Decision Date | 1994-01-18 |