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510(k) K150039

MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) by Siemens Healthcare Diagnostics, Inc. — Product Code LTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2015
Date Received
January 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Panels, Test, Susceptibility, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

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Other clearances for product code LTT

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  • K193536 — MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - (March 18, 2020)
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