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510(k) K021169

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

K021169 is an FDA 510(k) premarket notification submitted by Dade Microscan, Inc. for the device "MICROSTREP PLUS PANEL, AZITHROMYCIN". The FDA issued a decision of Substantially Equivalent on June 6, 2002. The device falls under product code JWY (Manual Antimicrobial Susceptibility Test Systems), a Class II device regulated under 21 CFR 866.1640. Dade Microscan, Inc. has at least 10 other 510(k) clearances on record.

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)
  • K021110 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE (June 6, 2002)
  • K021078 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN (June 6, 2002)
  • K021188 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME (June 6, 2002)
  • K021111 — MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME (June 6, 2002)
  • K020938 — MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM (June 3, 2002)

Other clearances for product code JWY

  • K260447 — ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (April 21, 2026)
  • K260696 — MTS Gepotidacin 0.016-256 µg/mL (April 17, 2026)
  • K252114 — MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (October 2, 2025)
  • K252062 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin (September 25, 2025)
  • K250575 — The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreon (September 5, 2025)
  • K252014 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin (August 28, 2025)
  • K251580 — MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (August 20, 2025)
  • K250990 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciproflox (June 30, 2025)
  • K242843 — The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) M (June 20, 2025)
  • K250856 — ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (June 12, 2025)

FDA data resources