Microstrep Plus Panel Amoxicillin/Clavulanic Acid
FDA 510(k) K062596 · Dade Behring, Inc.
510(k) numberK062596
Submission
- Device name
- Microstrep Plus Panel Amoxicillin/Clavulanic Acid
- Applicant
- Dade Behring, Inc.
West Sacramento, CA, US - Received
- September 1, 2006
- Decision date
- September 19, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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Questions and answers
When was Microstrep Plus Panel Amoxicillin/Clavulanic Acid cleared by the FDA?
Microstrep Plus Panel Amoxicillin/Clavulanic Acid (K062596) received a 510(k) decision of Substantially Equivalent on September 19, 2006, 18 days after the submission was received.
What is the product code of K062596?
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.