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510(k) K020506

MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEFTRIAXONE (0.5-128 UG/ML) by Dade Microscan, Inc. — Product Code LON

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2002
Date Received
February 15, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class
Class II
Regulation Number
866.1645
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)
  • K021169 — MICROSTREP PLUS PANEL, AZITHROMYCIN (June 6, 2002)
  • K021078 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN (June 6, 2002)
  • K021111 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME (June 6, 2002)

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