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510(k) K021169

MICROSTREP PLUS PANEL, AZITHROMYCIN by Dade Microscan, Inc. — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2002
Date Received
April 11, 2002
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 Dade Microscan, Inc.

  • K043589 — MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM (February 14, 2005)
  • K023202 — MICROSCAN SYNERGIES PLUS (October 23, 2002)
  • K021184 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN (June 20, 2002)
  • K021181 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN (June 17, 2002)
  • K021018 — MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL (June 11, 2002)
  • K021188 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME (June 6, 2002)
  • K021110 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE (June 6, 2002)
  • K021111 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME (June 6, 2002)
  • K021078 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN (June 6, 2002)
  • K020938 — MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM (June 3, 2002)

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