Autoscan W/A System
FDA 510(k) K854448 · American Micro Scan
510(k) numberK854448
Submission
- Device name
- Autoscan W/A System
- Applicant
- American Micro Scan
Sacramento, CA, US - Received
- November 5, 1985
- Decision date
- November 26, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTO – Discs, Strips And Reagents, Microorganism Differentiation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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| K970834 | Gram SwabJTO · Traditional | Remel, Inc. | 04/17/1997SE |
| K970833 | Indole SwabJTO · Traditional | Remel, Inc. | 04/02/1997SE |
| K970009 | Lyfo(Tm) Differential Disk-BacitracinJTO · Traditional | Microbiologics, Inc. | 02/06/1997SE |
| K962966 | Ids Rapid CB Plus SystemJTO · Traditional | Innovative Diagnostic Systems, Inc. | 10/08/1996SE |
| K961191 | ColiscreenJTO · Traditional | Hardy Diagnostics | 06/17/1996SE |
| K960996 | M. Cat Butyrate DiskJTO · Traditional | Hardy Diagnostics | 04/18/1996SE |
| K955826 | Gibson Id-M. Cat.JTO · Traditional | Gibson Laboratories, Inc. | 02/29/1996SE |
| K954783 | Dryslide CartarrhalisJTO · Traditional | Difco Laboratories, Inc. | 02/06/1996SE |
More from Difco Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| K864662 | Chlamydiae Fluor. AB Test for Detection in SmearsLJP · Traditional | 03/25/1987SE |
| K863776 | Microdilution Mic PanelsJWY · Traditional | 02/02/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | 01/05/1987SE |
| K864389 | Chlamydiae Flourescent Monoclonal Antibody TestLJP · Traditional | 12/04/1986SE |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | 09/30/1986SE |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | 09/11/1986SE |
| K862332 | Anaerobe Rapid Chromogenic Id PanelJSP · Traditional | 08/27/1986SE |
| K862140 | Microdilution PanelsJWY · Traditional | 07/16/1986SE |
| K861584 | Gram Negative Combo Panel Type 3JWY · Traditional | 06/17/1986SE |
Questions and answers
When was Autoscan W/A System cleared by the FDA?
Autoscan W/A System (K854448) received a 510(k) decision of Substantially Equivalent on November 26, 1985, 21 days after the submission was received.
What is the product code of K854448?
The FDA product code is JTO – Discs, Strips And Reagents, Microorganism Differentiation, a Class I (low risk) device regulated under 21 CFR 866.2660.