2700 Sample Manager
FDA 510(k) K980180 · Waters Corporation
510(k) numberK980180
Submission
- Device name
- 2700 Sample Manager
- Applicant
- Waters Corporation
Milford, MA, US - Received
- January 20, 1998
- Decision date
- February 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K951753 | Medtec Autoblot 2000JQW · Traditional | Medtec, Inc. | 10/17/1995SE |
More from Medtec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K063868 | Masstrak Immunosuppressants KitMLM · Traditional | 05/25/2007SE |
| K973074 | 2487 Dual Wavelength Absorbance DetectorKZR · Traditional | 10/06/1997SE |
| K964588 | Waters 515 HPLC Pump (515)KIE · Traditional | 11/29/1996SE |
| K962574 | Waters 474 Scanning Flourescence Detector (474)LEQ · Traditional | 07/22/1996SE |
| K961557 | Alliance 2690 Separations ModuleLDM · Traditional | 07/05/1996SE |
Questions and answers
When was 2700 Sample Manager cleared by the FDA?
2700 Sample Manager (K980180) received a 510(k) decision of Substantially Equivalent on February 12, 1998, 23 days after the submission was received.
What is the product code of K980180?
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.