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510(k) K842532

AMIZYME-ANA TEST KIT by Amico Lab, Inc. — Product Code LJM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1984
Date Received
June 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Amico Lab, Inc.

  • K842662 — ANTI-EPSTEIN-BARR VIRUS KIT (December 12, 1985)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (December 6, 1985)
  • K842661 — ANTI-CYTOMEGALOVIRUS KIT (December 6, 1985)
  • K842529 — AMIZYME-CMV KIT (December 6, 1985)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)
  • K842530 — AMIZYME-EBV TEST KIT (December 6, 1985)
  • K842660 — ANTI-SCHISTOSOMA SPECIES KIT (October 30, 1984)
  • K842525 — AMIZYME-C TRACHOMATIS TEST KIT (October 1, 1984)
  • K842658 — ANTI-CHLAMYDIA TRACHOMATIS KIT (October 1, 1984)
  • K842533 — AMIZYME-ANDNA TEST KIT (September 20, 1984)

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