The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Calibration Solution 1, Model A943-837; Calibration Solution 2, Model A943-839; Rinse Solution Kit, Model A943-838.
| Device ID | K001484 |
| 510k Number | K001484 |
| Device Name: | CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 -2048 |
| Contact | Patrick Chiu |
| Correspondent | Patrick Chiu ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 -2048 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-11 |
| Decision Date | 2000-06-19 |