Microscan Dri Gram Posit/Gram Nega Mic/Combo Panel
FDA 510(k) K922482 · Baxter Diagnostics, Inc.
510(k) numberK922482
Submission
- Device name
- Microscan Dri Gram Posit/Gram Nega Mic/Combo Panel
- Applicant
- Baxter Diagnostics, Inc.
West Sacramento, CA, US - Received
- May 27, 1992
- Decision date
- March 12, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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| K111205 | Microscan (R) Microstrep Plus (R) PanelsLRG · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/20/2011SE |
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| K081013 | Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test Cefoxitin ScreenLRG · Traditional | Siemens Healthcare Diagnostics | 09/08/2008SE |
| K071316 | Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Streptomycin…LRG · Traditional | Dade Behring, Inc. | 08/20/2007SE |
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More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K934458 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 07/18/1995SE |
| K950817 | Dried Gram Positive Mic/Combo Panels/PneumococciJWY · Traditional | 04/25/1995SE |
| K935704 | Dried Gram-Negative Mic//Combo PanelsLTT · Traditional | 04/14/1995SE |
| K950570 | Stratus Progesterone Fluorometric Enzyme ImmunoassayJLS · Traditional | 04/11/1995SE |
| K945235 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | 03/07/1995SE |
| K941030 | Dried Gram-Negative CefpodoximeLTT · Traditional | 02/16/1995SE |
| K940917 | Loracarbef Gram-Nagative PanelsJWY · Traditional | 02/08/1995SE |
| K941459 | Gram Positive Dried Overnight Panels/LomefloxJWY · Traditional | 02/03/1995SE |
| K941317 | Dried Gram Negative/CefmetazoleJWY · Traditional | 01/31/1995SE |
| K942267 | Dried Gram-Positive Mic/Combo Panels/CefmetazoleJWY · Traditional | 01/09/1995SE |
Questions and answers
When was Microscan Dri Gram Posit/Gram Nega Mic/Combo Panel cleared by the FDA?
Microscan Dri Gram Posit/Gram Nega Mic/Combo Panel (K922482) received a 510(k) decision of Substantially Equivalent on March 12, 1993, 289 days after the submission was received.
What is the product code of K922482?
The FDA product code is LRG – Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.