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510(k) K011116

PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST by Pasco Laboratories, Inc. — Product Code LTT

K011116 is an FDA 510(k) premarket notification submitted by Pasco Laboratories, Inc. for the device "PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST". The FDA issued a decision of Substantially Equivalent on April 24, 2001. The device falls under product code LTT (Panels, Test, Susceptibility, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Pasco Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2001
Date Received
February 21, 2001
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

Other clearances by Pasco Laboratories, Inc.

  • K042331 — PASCO MIC AND MIC/ID PANELS (October 7, 2004)
  • K041776 — PASCO MIC AND MIC/ID PANELS (August 3, 2004)
  • K041214 — PASCO MIC AND MIC/ID PANELS (June 7, 2004)
  • K033119 — PASCO MIC AND MIC/ID PANELS (November 18, 2003)
  • K031727 — PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (July 30, 2003)
  • K031205 — PASCO MIC AND MIC/ID PANELS (June 13, 2003)
  • K031103 — PASCO MIC AND MIC/ID PANELS (ERTAPENEM) (June 12, 2003)
  • K030933 — PASCO MIC AND MIC/ID PANELS (May 1, 2003)
  • K030620 — PASCO MIC AND MIC/ID PANELS (April 14, 2003)
  • K020331 — PASCO MIC AND MIC/ID PANELS (March 20, 2002)

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