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510(k) K002139

ETEST LINEZOLID by Ab Biodisk — Product Code LTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2000
Date Received
July 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Discs, Elution
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type

Other clearances by Ab Biodisk

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  • K042390 — ETEST FOR GEMIFLOXACIN (November 19, 2004)
  • K040560 — ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING (July 27, 2004)
  • K021445 — ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE (June 6, 2002)
  • K020748 — ETEST ERTAPENEM (April 29, 2002)
  • K010363 — ETEST MEROPENEM (April 9, 2001)
  • K001547 — ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP (August 7, 2000)
  • K000596 — ETEST GATIFLOXACIN (May 22, 2000)

Other clearances for product code LTX

  • K992993 — ETEST FOR QUINUPRISTIN/DALFOPRISTIN (November 16, 1999)