Mic-Concept Inoculum Seed Tray
FDA 510(k) K851019 · Microtech Medical Systems, Inc.
510(k) numberK851019
Submission
- Device name
- Mic-Concept Inoculum Seed Tray
- 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
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|---|---|---|
| K935485 | Fas Fastidious Mic PanelJWY · Traditional | 02/16/1995SE |
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| 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 Inoculum Seed Tray cleared by the FDA?
Mic-Concept Inoculum Seed Tray (K851019) 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 K851019?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.