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510(k) K842526

AMIZYME-LEISHMANIA SPP. TEST KIT by Amico Lab, Inc. — Product Code LOO

K842526 is an FDA 510(k) premarket notification submitted by Amico Lab, Inc. for the device "AMIZYME-LEISHMANIA SPP. TEST KIT". The FDA issued a decision of Substantially Equivalent on August 28, 1984. The device falls under product code LOO (Reagent, Leishmanii Serological), a Class I device regulated under 21 CFR 866.3870. Amico Lab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

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

Device Classification

Device Name
Reagent, Leishmanii Serological
Device Class
Class I
Regulation Number
866.3870
Review Panel
MI
Submission Type

Other clearances by Amico Lab, Inc.

  • K842662 — ANTI-EPSTEIN-BARR VIRUS KIT (December 12, 1985)
  • K842661 — ANTI-CYTOMEGALOVIRUS KIT (December 6, 1985)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)
  • K842530 — AMIZYME-EBV TEST KIT (December 6, 1985)
  • K842529 — AMIZYME-CMV KIT (December 6, 1985)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (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)

Other clearances for product code LOO

  • K023483 — KALAZAR DETECT (May 6, 2003)

FDA data resources