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510(k) K854490

IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES by American Micro Scan — Product Code GRP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1985
Date Received
November 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Types, H. Influenza
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

Other clearances by American Micro Scan

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  • 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)
  • K862140 — MICRODILUTION PANELS (July 16, 1986)
  • K861584 — GRAM NEGATIVE COMBO PANEL TYPE 3 (June 17, 1986)

Other clearances for product code GRP

  • K884967 — BACTIGEN(R) H. INFLUENZAE TYPE B (February 7, 1989)
  • K831525 — H-FLU B ELISA TEST (September 29, 1983)
  • K823348 — H. INFLUENZA B ANTISERA FOR CIE (December 28, 1982)
  • K821266 — BBL DIRECTIGEN MENINGITIS TEST KIT (June 1, 1982)
  • K820192 — HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (March 11, 1982)