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510(k) K091949

MICROSCAN MICROSTREP PLUS, MODEL B1027-201 by Siemens Healthcare Diagnostics — Product Code LTT

K091949 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "MICROSCAN MICROSTREP PLUS, MODEL B1027-201". The FDA issued a decision of Substantially Equivalent on January 26, 2010. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2010
Date Received
July 1, 2009
Clearance Type
Special
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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  • K241165 — Atellica® IM High-Sensitivity Troponin I (TnIH) (July 25, 2024)

Other clearances for product code LTT

  • K243804 — MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/m (August 20, 2025)
  • K250036 — MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg (August 15, 2025)
  • K250084 — MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/m (July 18, 2025)
  • K202343 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg (November 16, 2020)
  • K201423 — MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg (June 29, 2020)
  • K193536 — MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - (March 18, 2020)
  • K193358 — MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16 (March 3, 2020)
  • K183127 — MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/ (February 12, 2019)
  • K172337 — MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/ (December 15, 2017)
  • K172912 — MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µ (December 7, 2017)

FDA data resources