Wellprep 1
FDA 510(k) K913567 · Denley Instruments, Inc.
510(k) numberK913567
Submission
- Device name
- Wellprep 1
- Applicant
- Denley Instruments, Inc.
Bethesda, MD, US - Received
- August 9, 1991
- Decision date
- October 4, 1991
- 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 |
| 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 |
|---|---|---|
| K922803 | Wellwash 4 Mark IIJQW · Traditional | 11/05/1992SE |
| K922327 | Denley Wellprep 2 Sample ProcessorJQW · Traditional | 08/12/1992SE |
| K922183 | Wellprep 2000 Sample ProcessorJQW · Traditional | 08/11/1992SE |
| K915284 | Stacking Microplate WasherJQW · Traditional | 01/22/1992SE |
| K900599 | Microplate Reagent DispenserJQW · Traditional | 05/17/1990SE |
| K894272 | Denley Welldill 3JQW · Traditional | 08/21/1989SE |
| K894270 | Denley Anthos 2001 ReaderJJQ · Traditional | 08/21/1989SE |
| K894271 | Denley Wellwash 2 and 4JQW · Traditional | 08/15/1989SE |
Questions and answers
When was Wellprep 1 cleared by the FDA?
Wellprep 1 (K913567) received a 510(k) decision of Substantially Equivalent on October 4, 1991, 56 days after the submission was received.
What is the product code of K913567?
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.