The following data is part of a premarket notification filed by Andronic Devices, Ltd. with the FDA for Autoquot Automated Aliquotting System.
| Device ID | K934124 |
| 510k Number | K934124 |
| Device Name: | AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | ANDRONIC DEVICES, LTD. SUITE 140 13120 VANIER PLACE Richmond, B.c. Canada V6v 2j2, CA V6v 2j2 |
| Contact | Robert Macniel |
| Correspondent | Robert Macniel ANDRONIC DEVICES, LTD. SUITE 140 13120 VANIER PLACE Richmond, B.c. Canada V6v 2j2, CA V6v 2j2 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-25 |
| Decision Date | 1994-04-13 |