Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 Mcg/Ml
FDA 510(k) K032706 · Dade Behring, Inc.
510(k) numberK032706
Submission
- Device name
- Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 Mcg/Ml
- Applicant
- Dade Behring, Inc.
West Sacramento, CA, US - Received
- September 2, 2003
- Decision date
- February 10, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWY – Manual Antimicrobial Susceptibility Test Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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Questions and answers
When was Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 Mcg/Ml cleared by the FDA?
Microscan Dried Gram-Negative Mic/Combo Panels with Ertapenem (0.002-32 Mcg/Ml (K032706) received a 510(k) decision of Substantially Equivalent on February 10, 2004, 161 days after the submission was received.
What is the product code of K032706?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.