Autodiluter III
FDA 510(k) K810659 · Dynatech Corp.
510(k) numberK810659
Submission
- Device name
- Autodiluter III
- Applicant
- Dynatech Corp.
Mchenry, IL, US - Received
- March 11, 1981
- Decision date
- March 31, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTC – Device, Microtiter Diluting/Dispensing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2500
- Specialty
- Microbiology
Other 510(k)s with product code JTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924907 | Filtermate Universal HarvesterJTC · Traditional | Packard Instrument Co., Inc. | 12/01/1992SE |
| K901808 | Micromate 196 Model A961960JTC · Traditional | Packard Instrument Co., Inc. | 06/20/1990SE |
| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | Dynatech Laboratories, Inc. | 10/17/1989SE |
| K892369 | Multi-Probe Head PlusJTC · Traditional | Hamilton Co. | 06/02/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K891766 | Genetic Systems Microplate Strip WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K891765 | Genetic Systems Pipettor/DilutorJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K884695 | Washer 500 Microelisa SystemJTC · Traditional | Organon Teknika Corp. | 12/13/1988SE |
| K884125 | Bio-Tek Automated Microplate Washer Model EL403JTC · Traditional | Bio-Tek Instruments, Inc. | 12/02/1988SE |
| K874598 | Dynatech MR 250 Manual Microelisa ReaderJTC · Traditional | Dynatech Laboratories, Inc. | 11/20/1987SE |
More from Dynatech Laboratories, 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 Autodiluter III cleared by the FDA?
Autodiluter III (K810659) received a 510(k) decision of Substantially Equivalent on March 31, 1981, 20 days after the submission was received.
What is the product code of K810659?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.