Mic-Concept System
FDA 510(k) K852613 · Microtech Medical Systems, Inc.
510(k) numberK852613
Submission
- Device name
- Mic-Concept System
- Applicant
- Microtech Medical Systems, Inc.
Aurora, CO, US - Received
- June 19, 1985
- Decision date
- September 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LTW – Susceptibility Test Cards, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code LTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K853772 | Precept MethicillinLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853685 | Precept TM CarbenicillinLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853596 | Precept CefoperazoneLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853273 | Precept CeftriaxoneLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853689 | Precept TM MoxalactamLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853688 | Precept TM TobramycinLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853687 | Precept Netilmicin 32-13LTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853686 | Precept TM AmikacinLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853684 | Precept KanamycinLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853263 | Precept AvgmentinLTW · Traditional | Austin Biological Laboratories | 08/29/1985SE |
More from Austin Biological Laboratories
| 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 |
| K853745 | Mic-Concept ViewboxLIB · Traditional | 09/19/1985SE |
| K850725 | Quadra Titer Micro PlatesLIB · Traditional | 04/30/1985SE |
| K851020 | Mic-Concept InoculatorJTC · Traditional | 03/29/1985SE |
Questions and answers
When was Mic-Concept System cleared by the FDA?
Mic-Concept System (K852613) received a 510(k) decision of Substantially Equivalent on September 20, 1985, 93 days after the submission was received.
What is the product code of K852613?
The FDA product code is LTW – Susceptibility Test Cards, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.