Autoquot Automated Aliquotting System
FDA 510(k) K934124 · Andronic Devices, Ltd.
510(k) numberK934124
Submission
- Device name
- Autoquot Automated Aliquotting System
- Applicant
- Andronic Devices, Ltd.
Richmond, B.C. Canada V6v 2j2, CA - Received
- August 25, 1993
- Decision date
- April 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JQW – Station, Pipetting And Diluting, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2750
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023955 | BD Viper InstrumentJQW · Traditional | Becton, Dickinson & CO | 06/24/2003SE |
| K973335 | Quatro SP Sample Processing Systems (200-499, Inclusive)JQW · Traditional | Zenyx Scientific , Ltd. | 04/30/1998SE |
| K980180 | 2700 Sample ManagerJQW · Traditional | Waters Corporation | 02/12/1998SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | Pharmacia, Inc. | 06/30/1997SE |
| K970616 | Mini Sampler ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 04/21/1997SE |
| K962687 | Gio. de Vita E C. S.R.L.(Gdv) Automatic Washing SystemJQW · Traditional | Nichols Institute Diagnostics | 03/28/1997SE |
| K962859 | Mini Sample ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 10/29/1996SE |
| K961896 | Microlab 4000, Microlab 4200JQW · Traditional | Hamilton Co. | 08/16/1996SE |
| K961694 | ImpactJQW · Traditional | Matrix Technologies Corp. | 06/21/1996SE |
| K953345 | GenesisJQW · Traditional | Tecan U.S., Inc. | 11/21/1995SE |
More from Tecan U.S., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940812 | Insight Electronic Alignment IndicatorKQX · Traditional | 11/21/1994SE |
| K934928 | Insite Filter & Tubing SetHIF · Traditional | 05/26/1994SE |
| K934926 | Insite Model 20 & Model 15 InsufflatorsHIF · Traditional | 05/26/1994SE |
| K935381 | Kaps Positioning ArmFWZ · Traditional | 04/15/1994SE |
| K936308 | Endex Endoscopic Positioning SystemFQO · Traditional | 03/31/1994SE |
| K932253 | Arthrobot Bi-Fold DrapeKKX · Traditional | 02/03/1994SE |
| K922626 | Adept Instrument Positioning AccessoryGAD · Traditional | 10/19/1992SE |
| K922625 | Adept Endoscopic PositionerGAD · Traditional | 10/19/1992SE |
| K911521 | Arthrobot(Tm) 96 (240 CM) Drape with 1 StrapKKX · Traditional | 08/02/1991SE |
| K911520 | Arthrobot(Tm) 75 (190 CM) General Purpose DrapeKKX · Traditional | 08/02/1991SE |
Questions and answers
When was Autoquot Automated Aliquotting System cleared by the FDA?
Autoquot Automated Aliquotting System (K934124) received a 510(k) decision of Substantially Equivalent on April 13, 1994, 231 days after the submission was received.
What is the product code of K934124?
The FDA product code is JQW – Station, Pipetting And Diluting, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2750.