Mic-Concept Inoculator
FDA 510(k) K851020 · Microtech Medical Systems, Inc.
510(k) numberK851020
Submission
- Device name
- Mic-Concept Inoculator
- Applicant
- Microtech Medical Systems, Inc.
Aurora, CO, US - Received
- March 12, 1985
- Decision date
- March 29, 1985
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K935485 | Fas Fastidious Mic PanelJWY · Traditional | 02/16/1995SE |
| K901598 | Fastidious Mic PanelJWY · Traditional | 11/08/1990SE |
| K896332 | Supplement to Anaerobic Mic PanelJWY · Traditional | 02/05/1990SE |
| K884831 | Anaerobic Mic PanelJWY · Traditional | 03/27/1989SE |
| K863847 | Mic - Concept(Tm) RX-2JWY · Traditional | 12/18/1986SE |
| K861774 | Quadra-Titer (TM) I.D. (Modification)JSS · Traditional | 05/20/1986SE |
| K860208 | Quadra-Titer I.D.JSS · Traditional | 03/03/1986SE |
| K852613 | Mic-Concept SystemLTW · Traditional | 09/20/1985SE |
| K853745 | Mic-Concept ViewboxLIB · Traditional | 09/19/1985SE |
| K850725 | Quadra Titer Micro PlatesLIB · Traditional | 04/30/1985SE |
Questions and answers
When was Mic-Concept Inoculator cleared by the FDA?
Mic-Concept Inoculator (K851020) received a 510(k) decision of Substantially Equivalent on March 29, 1985, 17 days after the submission was received.
What is the product code of K851020?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.