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510(k) K002139

ETEST LINEZOLID by Ab Biodisk — Product Code LTX

K002139 is an FDA 510(k) premarket notification submitted by Ab Biodisk for the device "ETEST LINEZOLID". The FDA issued a decision of Substantially Equivalent on November 8, 2000. The device falls under product code LTX (Discs, Elution), a Class II device regulated under 21 CFR 866.1620. Ab Biodisk has at least 10 other 510(k) clearances on record.

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

  • K081325 — ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML (July 24, 2008)
  • K052366 — ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BACTERIA, STREPTOCOCCU (October 13, 2005)
  • K042392 — DAPTOMYCIN (December 13, 2004)
  • 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)

FDA data resources