Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Gentamicin Synergy Screen
FDA 510(k) K071317 · Dade Behring, Inc.
510(k) numberK071317
Submission
- Device name
- Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Gentamicin Synergy Screen
- Applicant
- Dade Behring, Inc.
West Sacramento, CA, US - Received
- May 10, 2007
- Decision date
- August 20, 2007
- 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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Questions and answers
When was Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Gentamicin Synergy Screen cleared by the FDA?
Microscan Synergies Plus Gram Positive Mic/Combo Panels New Antimicrobial-Gentamicin Synergy Screen (K071317) received a 510(k) decision of Substantially Equivalent on August 20, 2007, 102 days after the submission was received.
What is the product code of K071317?
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.