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510(k) K842531

AMIZYME-HSV TYPES 1 & 2 TEST KITS by Amico Lab, Inc. — Product Code GQO

K842531 is an FDA 510(k) premarket notification submitted by Amico Lab, Inc. for the device "AMIZYME-HSV TYPES 1 & 2 TEST KITS". The FDA issued a decision of Substantially Equivalent on December 6, 1985. The device falls under product code GQO (Antisera, Cf, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Amico Lab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1985
Date Received
June 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
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)
  • K842530 — AMIZYME-EBV TEST KIT (December 6, 1985)
  • K842661 — ANTI-CYTOMEGALOVIRUS KIT (December 6, 1985)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (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)
  • K842532 — AMIZYME-ANA TEST KIT (September 20, 1984)

Other clearances for product code GQO

  • K883282 — VIRGO HSV-1 IGG ELISA (March 10, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM (June 7, 1988)
  • K875366 — THE DDI SERODOT HERPES IGG TEST KIT (May 23, 1988)
  • K871426 — VIROGEN HSV ANTIBODY TEST (October 15, 1987)
  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K854712 — VISIBLE-HERPES TM TEST SYSTEM (May 20, 1986)
  • K852781 — HSV2 - IGG ELISA-KIT (January 21, 1986)
  • K852782 — HSVI - IGG ELISA-KIT (January 21, 1986)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)

FDA data resources