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510(k) K862140

MICRODILUTION PANELS by American Micro Scan — Product Code JWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1986
Date Received
June 4, 1986
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 American Micro Scan

  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K864662 — CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (March 25, 1987)
  • K863776 — MICRODILUTION MIC PANELS (February 2, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K864389 — CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST (December 4, 1986)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)
  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)
  • K861584 — GRAM NEGATIVE COMBO PANEL TYPE 3 (June 17, 1986)
  • K860575 — YEAST IDENTIFICATION PANEL (May 13, 1986)

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