MIC-2000 Inoculum Tray Lid
FDA 510(k) K810039 · Dynatech Corp.
510(k) numberK810039
Submission
- Device name
- MIC-2000 Inoculum Tray Lid
- Applicant
- Dynatech Corp.
Mchenry, IL, US - Received
- January 9, 1981
- Decision date
- January 28, 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
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| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | Dynatech Laboratories, Inc. | 10/17/1989SE |
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| K891766 | Genetic Systems Microplate Strip WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
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| 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 MIC-2000 Inoculum Tray Lid cleared by the FDA?
MIC-2000 Inoculum Tray Lid (K810039) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 19 days after the submission was received.
What is the product code of K810039?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.