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510(k) K875366

THE DDI SERODOT HERPES IGG TEST KIT by Disease Detection International, Inc. — Product Code GQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1988
Date Received
December 31, 1987
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

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Other clearances for product code GQO

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  • 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)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (December 6, 1985)