Synergies Plus Gram-Positive Mic/Combo Panels with Linezolid
FDA 510(k) K062705 · Dade Behring, Inc.
510(k) numberK062705
Submission
- Device name
- Synergies Plus Gram-Positive Mic/Combo Panels with Linezolid
- Applicant
- Dade Behring, Inc.
West Sacramento, CA, US - Received
- September 11, 2006
- Decision date
- October 20, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1645
- Specialty
- Microbiology
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| K232756 | ColibríLON · Traditional | Copan Wasp Srl | 12/27/2023SE |
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Questions and answers
When was Synergies Plus Gram-Positive Mic/Combo Panels with Linezolid cleared by the FDA?
Synergies Plus Gram-Positive Mic/Combo Panels with Linezolid (K062705) received a 510(k) decision of Substantially Equivalent on October 20, 2006, 39 days after the submission was received.
What is the product code of K062705?
The FDA product code is LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, a Class II (moderate risk) device regulated under 21 CFR 866.1645.