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510(k) K031727

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN by Pasco Laboratories, Inc. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2003
Date Received
June 3, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Manual Antimicrobial Susceptibility Test Systems
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)
  • 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)
  • K011116 — PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST (April 24, 2001)

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