Microerma System
FDA 510(k) K811001 · Dynatech Corp.
510(k) numberK811001
Submission
- Device name
- Microerma System
- Applicant
- Dynatech Corp.
Mchenry, IL, US - Received
- April 13, 1981
- Decision date
- May 1, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K904567 | Dynatech MR4000 Microplate ReaderJJQ · Traditional | 01/28/1991SE |
| K854604 | Auto MashLIB · Traditional | 12/06/1985SE |
| K854603 | Multi Mash 2000LIB · Traditional | 12/06/1985SE |
| K854602 | Mini Mash 2000LIB · Traditional | 12/06/1985SE |
| K832117 | Immulon Substrate Removawell StripsLIB · Traditional | 08/08/1983SE |
| K823787 | Handi-WashLIB · Traditional | 03/09/1983SE |
| K823833 | Micro Stix #011-010-5000 & HOLDER#5100LIB · Traditional | 03/08/1983SE |
| K830200 | Microelisa Minireader IILBI · Traditional | 02/16/1983SE |
| K823773 | Provial II #006-010-0201KDT · Traditional | 01/21/1983SE |
| K823557 | Removawell Plate LidLIB · Traditional | 12/28/1982SE |
Questions and answers
When was Microerma System cleared by the FDA?
Microerma System (K811001) received a 510(k) decision of Substantially Equivalent on May 1, 1981, 18 days after the submission was received.
What is the product code of K811001?
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.