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510(k) K842527

AMIZYME-SCHISTOSOMA SPP. TEST KIT by Amico Lab, Inc. — Product Code GNH

K842527 is an FDA 510(k) premarket notification submitted by Amico Lab, Inc. for the device "AMIZYME-SCHISTOSOMA SPP. TEST KIT". The FDA issued a decision of Substantially Equivalent on September 5, 1984. The device falls under product code GNH (Antigen, Fluorescent Antibody Test, Schistosoma Mansoni), a Class I device regulated under 21 CFR 866.3600. Amico Lab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1984
Date Received
June 28, 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)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)
  • K842530 — AMIZYME-EBV TEST KIT (December 6, 1985)
  • K842661 — ANTI-CYTOMEGALOVIRUS 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 GNH

  • K842660 — ANTI-SCHISTOSOMA SPECIES KIT (October 30, 1984)

FDA data resources