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510(k) K842660

ANTI-SCHISTOSOMA SPECIES KIT by Amico Lab, Inc. — Product Code GNH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1984
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
Device Class
Class I
Regulation Number
866.3600
Review Panel
MI
Submission Type

Other clearances by Amico Lab, Inc.

  • K842662 — ANTI-EPSTEIN-BARR VIRUS KIT (December 12, 1985)
  • K842529 — AMIZYME-CMV KIT (December 6, 1985)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)
  • K842661 — ANTI-CYTOMEGALOVIRUS KIT (December 6, 1985)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (December 6, 1985)
  • K842530 — AMIZYME-EBV TEST KIT (December 6, 1985)
  • K842658 — ANTI-CHLAMYDIA TRACHOMATIS KIT (October 1, 1984)
  • K842525 — AMIZYME-C TRACHOMATIS TEST KIT (October 1, 1984)
  • K842533 — AMIZYME-ANDNA TEST KIT (September 20, 1984)
  • K842532 — AMIZYME-ANA TEST KIT (September 20, 1984)

Other clearances for product code GNH

  • K842527 — AMIZYME-SCHISTOSOMA SPP. TEST KIT (September 5, 1984)