Microscan Microstrep Plus Panel, Clindamycin
FDA 510(k) K062777 · Dade Behring, Inc.
510(k) numberK062777
Submission
- Device name
- Microscan Microstrep Plus Panel, Clindamycin
- Applicant
- Dade Behring, Inc.
West Sacramento, CA, US - Received
- September 18, 2006
- Decision date
- October 10, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LTT – Panels, Test, Susceptibility, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
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| K183127 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam…LTT · Traditional | Beckman Coulter, Inc. | 02/12/2019SE |
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| K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 12/07/2017SE |
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Questions and answers
When was Microscan Microstrep Plus Panel, Clindamycin cleared by the FDA?
Microscan Microstrep Plus Panel, Clindamycin (K062777) received a 510(k) decision of Substantially Equivalent on October 10, 2006, 22 days after the submission was received.
What is the product code of K062777?
The FDA product code is LTT – Panels, Test, Susceptibility, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.