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510(k) K992993

ETEST FOR QUINUPRISTIN/DALFOPRISTIN by Ab Biodisk — Product Code LTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1999
Date Received
September 7, 1999
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

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  • K021445 — ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE (June 6, 2002)
  • K020748 — ETEST ERTAPENEM (April 29, 2002)
  • K010363 — ETEST MEROPENEM (April 9, 2001)
  • K002139 — ETEST LINEZOLID (November 8, 2000)
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Other clearances for product code LTX

  • K002139 — ETEST LINEZOLID (November 8, 2000)