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 |