Mic-Concept Viewbox
FDA 510(k) K853745 · Microtech Medical Systems, Inc.
510(k) numberK853745
Submission
- Device name
- Mic-Concept Viewbox
- Applicant
- Microtech Medical Systems, Inc.
Aurora, CO, US - Received
- September 9, 1985
- Decision date
- September 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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More from Dynatech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K935485 | Fas Fastidious Mic PanelJWY · Traditional | 02/16/1995SE |
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| 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 |
| K850725 | Quadra Titer Micro PlatesLIB · Traditional | 04/30/1985SE |
| K851020 | Mic-Concept InoculatorJTC · Traditional | 03/29/1985SE |
Questions and answers
When was Mic-Concept Viewbox cleared by the FDA?
Mic-Concept Viewbox (K853745) received a 510(k) decision of Substantially Equivalent on September 19, 1985, 10 days after the submission was received.
What is the product code of K853745?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.